ABRAX study

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