ABRAX study

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ABRAX study Inclusion criteria Patient´s identification and history Diagnostics Treatment Follow-up Recurrence
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ABRAX study
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Inclusion criteria
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Histologically confirmed invasive cervical cancer (Squamous cell carcinoma, Adenocarcinoma, Adenosquamous carcinoma) [No,Yes]
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Stage pT1a – pT2b [No,Yes]
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Patient referred for primary surgical treatment (including radical / simple hysterectomy / fertility sparing procedure) in combination with LN staging. [No,Yes]
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Intraoperative detection of LN involvement (micrometastases or macrometastases). Grossly involved lymph nodes OR SLN/LN intraoperative pathologic evaluation (frozen section). [No,Yes]
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Follow-up data available for ≥ 2 years [No,Yes]
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Surgery performed between January 2005 and December 2015 [No,Yes]
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Patient´s identification and history
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Date of birth (month/year)
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Second primary cancer (previous or simultaneous)
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Breast cancer [No,Yes]
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Date of diagnosis (year)
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Treatment
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Chemotherapy [No,Yes]
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Radiotherapy [No,Yes]
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Location
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Abdominal [No,Yes]
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Pelvic [No,Yes]
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Other fields [No,Yes]
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Surgery [No,Yes]
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Haematological malignancy [No,Yes]
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Date of diagnosis (year)
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Treatment
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Chemotherapy [No,Yes]
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Radiotherapy [No,Yes]
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Location
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Abdominal [No,Yes]
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Pelvic [No,Yes]
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Other fields [No,Yes]
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Surgery [No,Yes]
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Other [No,Yes]
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Cancer type description
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Date of diagnosis (year)
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Treatment
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Chemotherapy [No,Yes]
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Radiotherapy [No,Yes]
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Location
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Abdominal [No,Yes]
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Pelvic [No,Yes]
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Other fields [No,Yes]
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Surgery [No,Yes]
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Height (at the time of diagnosis)
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Weight (at the time of diagnosis)
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Performance status (ECOG at the time of diagnosis) [0,1,2,3,4,Not available]
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Diagnostics
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Date of first diagnosis (month/year)
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Diagnostic procedure [Biopsy,Conization (any technique including LEEP, LLETZ etc.),Other,Pap smear]
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Imaging method used for clinical staging before primary surgery
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CT [No,Yes]
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Expert sonography [No,Yes]
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MRI [No,Yes]
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PET [No,Yes]
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None [No,Yes]
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Not available [No,Yes]
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Pre-treatment clinical and radiological staging (TNM classification) [T1A1,T1A2,T1B1,T1B2,T2A1,T2A2,T2B]
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Largest tumor size on radiological staging
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Lymph nodes radiological staging [Normal,Not assessed,Not available]
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Histological type [Adeno,Adenosquamous,Other,Squamous]
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Horizontal dimension
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Depth of invasion
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Treatment
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Neoadjuvant chemotherapy was given [No,Yes]
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Neoadjuvant chemotherapy
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Regimen
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Carboplatin [No,Yes]
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Dose per cycle
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No of cycles [1,2,3,4,5]
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Paclitaxel [No,Yes]
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Dose per cycle
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No of cycles [1,2,3,4,5]
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Cisplatin [No,Yes]
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Dose per cycle
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No of cycles [1,2,3,4,5]
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Ifosfamide [No,Yes]
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Dose per cycle
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No of cycles [1,2,3,4,5]
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Etoposide [No,Yes]
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Dose per cycle
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No of cycles [1,2,3,4,5]
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Other [No,Yes]
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Regimen description
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Primary surgery
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Surgery date (month/year)
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Intraoperative detection of LN involvement (micrometastases or macrometastases)
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Macroscopic involvement = grossly involved lymph nodes (if confirmed by final pathology) [No,Yes]
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Microscopic involvement = SLN / LN intraoperative pathologic evaluation (frozen section) [No,Yes]
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Intraoperative histological evaluation of LN (frozen section)
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Type of LN submitted [Pelvic nonSLN lymph node(s),SLN]
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Selection of LN for frozen section [All harvested LN submitted,Anatomical localisation,Not available,SLN,Suspicious LN]
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No of SLN/LN evaluated intraoperatively
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Type of metastasis reported from intraoperative evaluation (enter the largest type) [Macrometastases,Micrometastases]
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Cervical/uterine procedure abandoned [No,Yes]
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Reasons for abandoning cervical/uterine procedure
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Distant metastatic spread of tumor [No,Yes]
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LN involvement [No,Yes]
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Local tumor spread [No,Yes]
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Other [No,Yes]
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Description
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Primary treatment
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Cervical/uterine procedure [Conization (any technique including LEEP, LLETZ etc.),Radical hysterectomy (including parametrectomy),Radical trachelectomy (including parametrectomy),Simple hysterectomy,Simple trachelectomy (cervix amputation without parametrectomy)]
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Parametrectomy (applied for radical hysterectomy and radical trachelectomy)
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Type [Nerve sparing,Not classified,Other,Simple hysterectomy,TMMR,Type A,Type B,Type C1,Type C2,Type D,Type II,Type III]
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Description
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Adnexal procedure
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Type [Adnexal preservation,BSO,Previous BSO,Salpingectomy and ovarian preservation]
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Extrapelvic transposition [No,Yes]
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Surgical approach [Laparo-vaginal,Laparoscopic,Open (laparotomy),Robotic,Vaginal]
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Lymph node staging
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SLN biopsy
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SLN biopsy was done [No,Yes]
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Laterality [Bilat,Unilat]
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Pelvic lymphadenectomy
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Pelvic lymphadenectomy was performed [No,Yes]
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Paraaortic lymphadenectomy
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Paraaortic lymphadenectomy was performed [No,Yes]
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Location
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Inframesenterial (below arteria mesenterica inferior) [No,Yes]
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Supramesenterial (up to the renal vessels) [No,Yes]
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Final histological report
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Cervix/Uterus
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Size of the tumor
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Largest tumor dimension (Sum of largest dimension of the specimen from therapeutic and diagnostic procedures)
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LVSI [No,Yes]
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Parametrial invasion
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Parametrial invasion detected [No,Yes]
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Laterality [Bilat,Unilat]
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Free vaginal margins [No,Yes]
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Final lymph node status
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SLN [No,Yes]
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No of SLN removed
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No of SLN with metastases
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SLN ultrastaging was performed [No,Yes]
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Type of metastases (enter the largest type) [Isolated tumor cells,Macrometastases,Micrometastases]
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Non-SLN pelvic LNs [No,Yes]
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No of LN removed
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No of LN with metastases
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Type of metastases (enter the largest type) [Isolated tumor cells,Macrometastases,Micrometastases]
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Size of the largest macrometastases
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Paraaortic LNs (if PALD performed) [No,Yes]
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No of LN removed
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No of LN with metastases
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Type of metastases (enter the largest type) [Isolated tumor cells,Macrometastases,Micrometastases]
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Surgical data
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Operation time
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Blood loss
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Surgical complication
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Bowel injury [No,Yes]
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Ureteral injury [No,Yes]
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Urinary bladder injury [No,Yes]
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Other [No,Yes]
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Description
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Serious early postoperative adverse-events ≥ 2 according to CTCAE grading (until 30th postoperative day)
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1. adverse event [No,Yes]
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Type [Blood,Gastrointestinal,Infections,Other,Renal,Respiratory,Skin,Surgical,Vascular]
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Grade [2,3,4,5]
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2. adverse event [No,Yes]
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Type [Blood,Gastrointestinal,Infections,Other,Renal,Respiratory,Skin,Surgical,Vascular]
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Grade [2,3,4,5]
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3. adverse event [No,Yes]
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Type [Blood,Gastrointestinal,Infections,Other,Renal,Respiratory,Skin,Surgical,Vascular]
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Grade [2,3,4,5]
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4. adverse event [No,Yes]
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Type [Blood,Gastrointestinal,Infections,Other,Renal,Respiratory,Skin,Surgical,Vascular]
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Grade [2,3,4,5]
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5. adverse event [No,Yes]
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Type [Blood,Gastrointestinal,Infections,Other,Renal,Respiratory,Skin,Surgical,Vascular]
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Grade [2,3,4,5]
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Type of primary treatment [Chemotherapy only,Other,Radiochemotherapy,Radiotherapy only]
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Description of treatment
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External beam radiotherapy [No,Yes]
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Type [2D,3D,IMRT]
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Machine [Cobalt source,Linear accelerator]
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Area treated [Extended to paraaortic LN,Pelvis only]
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Duration
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Total dose
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Number of fractions
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Brachytherapy [No,Yes]
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Type [High dose rate,Low dose rate,PDR]
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Total dose
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Number of fractions
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Concomitant chemotherapy
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Regimen
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Carboplatin [No,Yes]
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Dose per cycle
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No of cycles [1,2,3,4,5]
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Cisplatin [No,Yes]
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Dose per cycle
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No of cycles [1,2,3,4,5]
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Other [No,Yes]
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Description
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Overall treatment (radiotherapy) time
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Reason why concomitant chemotherapy was not applied
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Impaired renal function [No,Yes]
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Local standard [No,Yes]
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Poor performance status [No,Yes]
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Other [No,Yes]
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Description
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Regimen
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Carboplatin [No,Yes]
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Dose per cycle
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No of cycles [1,2,3,4,5]
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Cisplatin [No,Yes]
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Dose per cycle
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No of cycles [1,2,3,4,5]
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Docetaxel [No,Yes]
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Dose per cycle
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No of cycles [1,2,3,4,5]
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Paclitaxel [No,Yes]
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Dose per cycle
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No of cycles [1,2,3,4,5]
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Topotecan [No,Yes]
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Dose per cycle
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No of cycles [1,2,3,4,5]
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Other [No,Yes]
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Description
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Reason why radiotherapy was not given
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Impaired renal function [No,Yes]
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Local standard [No,Yes]
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Poor performance status [No,Yes]
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Other [No,Yes]
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Description
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Adjuvant treatment was given [No,Yes]
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Adjuvant treatment
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Indication
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LN involvement [No,Yes]
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Parametrial involvement [No,Yes]
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Sedlis criteria (high risk tumor based on the size, stromal invasion, LVSI) [No,Yes]
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Other [No,Yes]
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Type of adjuvant treatment [Chemotherapy only,Other,Radiochemotherapy,Radiotherapy only]
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Description of adjuvant treatment
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Brachytherapy [No,Yes]
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Type [High dose rate,Low dose rate,PDR]
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Total dose
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Number of fractions
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Date when adjuvant treatment was finished (month/year)
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External beam radiotherapy [No,Yes]
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Type [2D,3D,IMRT]
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Machine [Cobalt source,Linear accelerator]
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Area treated [Extended to paraaortic LN,Pelvis only]
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Duration
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Total dose
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Number of fractions
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Concomitant chemotherapy
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Regimen
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Carboplatin [No,Yes]
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Dose per cycle
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No of cycles [1,2,3,4,5]
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Cisplatin [No,Yes]
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Dose per cycle
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No of cycles [1,2,3,4,5]
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Other [No,Yes]
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Description
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Overall treatment (radiotherapy) time
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Reason why concomitant chemotherapy was not applied
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Impaired renal function [No,Yes]
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Local standard [No,Yes]
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Poor performance status [No,Yes]
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Other [No,Yes]
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Description
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Regimen
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Carboplatin [No,Yes]
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Dose per cycle
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No of cycles [1,2,3,4,5]
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Docetaxel [No,Yes]
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Dose per cycle
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No of cycles [1,2,3,4,5]
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Paclitaxel [No,Yes]
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Dose per cycle
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No of cycles [1,2,3,4,5]
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Cisplatin [No,Yes]
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Dose per cycle
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No of cycles [1,2,3,4,5]
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Topotecan [No,Yes]
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Dose per cycle
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No of cycles [1,2,3,4,5]
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Other [No,Yes]
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Description
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Reason why radiotherapy was not given
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Impaired renal function [No,Yes]
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Local standard [No,Yes]
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Poor performance status [No,Yes]
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Other [No,Yes]
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Description
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Date when treatment was finished (month/year)
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Method used for the response to definitive treatment assessment
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CT [No,Yes]
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MRI [No,Yes]
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PET [No,Yes]
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Physical examination [No,Yes]
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US [No,Yes]
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Definitive treatment outcome [Complete response,Partial response,Progressive disease,Stable disease]
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Follow-up
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Follow-up procedure
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CT [No,Yes]
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1. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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2. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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3. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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4. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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5. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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Expert ultrasound [No,Yes]
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1. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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2. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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3. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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4. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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5. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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Gynecological examination [No,Yes]
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1. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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2. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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3. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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4. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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5. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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HPV test [No,Yes]
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1. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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2. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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3. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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4. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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5. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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MRI [No,Yes]
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1. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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2. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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3. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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4. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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5. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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PET-CT [No,Yes]
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1. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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2. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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3. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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4. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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5. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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Pap smear [No,Yes]
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1. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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2. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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3. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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4. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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5. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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Physical examination [No,Yes]
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1. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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2. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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3. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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4. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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5. year [No,Yes]
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If clinically indicated [No,Yes]
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Routinely [No,Yes]
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Frequency every [12 month,3 month,6 month]
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Other regular tests/procedures [No,Yes]
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Description
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Late serious adverse events ≥ 2 CTCAE grading (associated with the treatment, since the 31st postoperative day)
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1. adverse event [No,Yes]
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Type [Blood,Gastrointestinal,Infections,Other,Renal,Respiratory,Skin,Surgical,Vascular]
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Grade [2,3,4,5]
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Date of 1st diagnosis (month/year)
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2. adverse event [No,Yes]
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Type [Blood,Gastrointestinal,Infections,Other,Renal,Respiratory,Skin,Surgical,Vascular]
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Grade [2,3,4,5]
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Date of 1st diagnosis (month/year)
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3. adverse event [No,Yes]
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Type [Blood,Gastrointestinal,Infections,Other,Renal,Respiratory,Skin,Surgical,Vascular]
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Grade [2,3,4,5]
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Date of 1st diagnosis (month/year)
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4. adverse event [No,Yes]
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Type [Blood,Gastrointestinal,Infections,Other,Renal,Respiratory,Skin,Surgical,Vascular]
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Grade [2,3,4,5]
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Date of 1st diagnosis (month/year)
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5. adverse event [No,Yes]
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Type [Blood,Gastrointestinal,Infections,Other,Renal,Respiratory,Skin,Surgical,Vascular]
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Grade [2,3,4,5]
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Date of 1st diagnosis (month/year)
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Date of last FU visit (month/year)
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Status at the time of the last FU visit [Alive with disease (AWD),Death,No evidence of disease (NED)]
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Date of death (month/year)
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Cause of death [Disease progression,Intercurrent disease,Other,Other cancer,Treatment complications]
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Recurrence
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Cancer recurred [No,Yes]
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Recurrence date (month/year)
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Site
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Pelvis [No,Yes]
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Central [No,Yes]
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Lateral [No,Yes]
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Preserved uterus involved [No,Yes]
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Abdomen [No,Yes]
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Thorax [No,Yes]
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Other distant [No,Yes]
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Symptoms at the time of diagnosis [No,Yes]
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Recurrence was treated [No,Yes]
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Treatment of recurrence
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Chemotherapy [No,Yes]
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Experimental [No,Yes]
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Immunotherapy [No,Yes]
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Radiochemotherapy [No,Yes]
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Radiotherapy [No,Yes]
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Secondary surgery [No,Yes]
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Targeted [No,Yes]
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Other [No,Yes]
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Description
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Treatment response
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Response of the 1st recurrence [Complete remission,Partial remission/stable disease,Progression]
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2nd recurrence [No,Yes]
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Third line treatment
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Chemotherapy [No,Yes]
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Experimental [No,Yes]
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Immunotherapy [No,Yes]
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Radiochemotherapy [No,Yes]
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Radiotherapy [No,Yes]
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Surgery [No,Yes]
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Targeted [No,Yes]
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Other [No,Yes]
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Description
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None [No,Yes]
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Third line treatment
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Chemotherapy [No,Yes]
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Experimental [No,Yes]
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Immunotherapy [No,Yes]
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Radiochemotherapy [No,Yes]
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Radiotherapy [No,Yes]
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Surgery [No,Yes]
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Targeted [No,Yes]
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Other [No,Yes]
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Description
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None [No,Yes]