ABRAX study

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]