Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-24 @ 6:55 PM
NCT ID:
NCT00426257
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 76 years
* Histological or cytological proven primary epithelial ovarian carcinoma or peritoneal cancer (PPSC) or fallopian tube carcinoma FIGO stage III, including serous papillary adenocarcinoma, mucinous adenocarcinoma and endometrioid adenocarcinoma.
* In case of pleural effusion cytology should be negative for tumour cells
* In case diagnosis is made based on cytology only (i.e. patients treated by primary chemotherapy) additional criteria apply:
* Normal mammogram (\< 6 weeks before first registration) and
* Presence of pelvic mass and
* CA 125 \> 200 kU/l and
* Serum CA125/CEA ratio \> 25. If the serum CA125/CEA ratio is \< 25, a barium enema or colonoscopy and gastroscopy or radiological examination of the stomach should be negative for the presence of a primary tumour of the digeste tract (\< 6 weeks before registration) and
* Omental cake or other metastases larger than 2 cm in the upper abdomen and/or regional lymph node metastasis irrespective of size (CT/MRI or ultrasound or laparoscopy)
* Patients eligible for interval debulking for the following 2 reasons:
* Primary debulking surgery not feasible due to tumour extension or general condition (patients treated by primary chemotherapy) or
* Incomplete primary debulking with residual disease \> 1 cm
* In case of primary chemotherapy:
* Chemotherapy consists of 3 courses of carboplatin or cisplatin combined with taxol
* Following 2 cycles of chemotherapy at least a 30% decrease in the sum of largest diameter (LD) of target lesions taking as reference the baseline sum LD (RECIST criteria, see appendix 1)
* In case of an incomplete primary debulking as indicated under 5 followed by chemotherapy:
* Chemotherapy consists of 3 courses of carboplatin or cisplatin combined with taxol
* General criteria:
* Fit for major surgery, ASA 1 or ASA 2
* WHO performance status 0-2
* Written informed consent
* Laboratory values: serum creatinine \< 140 µmol/L; creatinine clearance \> 60 ml/min (Cockroft formula); white blood cell count \> 3.5 x 109/l; platelets \> 100 x 109 /l
* For quality of life studies:
* Baseline questionnaires should be filled in before randomization
Exclusion Criteria:
* History of breast cancer or previous malignancies within 5 years prior to inclusion, with the exception of radically excised basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
76 Years
Study:
NCT00426257
Study Brief:
Protocol Section:
NCT00426257