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]