Phase III randomised clinical trial for stage III ovarian carcinoma randomising between secondary debulking surgery with or without hyperthermic intraperitoneal chemotherapy (OVHIPEC-I)
- Conditions
- ovarian cancer1003859710033283
- Registration Number
- NL-OMON38240
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 240
1. age between 18 and 76 years
2. 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.
3. in case of pleural effusion cytology should be negative for tumour cells
4. 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 first registration) and
§ Omental cake or other metastases larger than 2 cm in the upper abdomen and/or regional lymphnode metastasis irrespective of size (CT/MRI or ultrasound or laparoscopy)
5. 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
6. In case of primary chemotherapy:
- chemotherapy consists of 3 courses of carboplatin or cisplatin combined
with taxol
- Following 2 cycles of chemotherapy no progression should occur
7. 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
8. 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
9. For quality of life studies:
- baseline questionnaires should be filled in before randomisation
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Recurrence free survival </p><br>
- Secondary Outcome Measures
Name Time Method <p>toxicity;morbidity, quality of life; overall survival; tumour response</p><br>