ABRAX study//mm2html.xsl FreeplaneVersion:freeplane 1.6.0

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]
```

ABRAX study//mm2html.xsl FreeplaneVersion:freeplane 1.6.0