Topic: National Cancer Research Network
Conditions
Interventions
Arm A: upfront maximal cytoreductive surgery -
3 courses of platinum-containing chemo (3-weekly):
1. Paclitaxel 135 mg/m^2 (over 24 hours) then cisplatin 75 mg/m^2, or
2. Paclitaxel 175 mg/m^2 (over 3
every 6 months year 3 - 5
yearly afterwards.
Computed tomography (CT) scans were performed at screening, after cycle 3, after interval debulk (if perfomed) and after cycle 6. Progression defined according to Response Evaluat
Sponsors
European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Histologically proven stage IIIC or IV ovarian epithelial carcinoma, peritoneal carcinoma, or fallopian tube carcinoma 2. If biopsy is not available, evidence of adenocarcinoma by fine needle aspiration allowed if all of the following are true: 2.1. Presence of pelvic ovarian mass 2.2. Omental cake or other metastasis larger than 2 cm in the upper abdomen and/or regional lymph node metastasis 2.3. CA 125/carcinoembryonic antigen ratio greater than 25 (if ratio less than 25, barium enema or colonoscopy AND gastroscopy or radiological examination of the stomach must be negative for primary tumor) 2.4. Normal mammography (if CA 125/carcinoembryonic antigen ratio less than 25) 3. Tumor greater than 2 cm, excluding ovaries, on laparoscopy or CT scan 4. No brain or leptomeningeal metastases 5. No other prior procedures except diagnostic biopsy by laparotomy or laparoscopy 6. Performance status: World Health Organisation (WHO) performance status 0 - 2 7. WBC greater than 3,000/mm3 8. Platelet count greater than 100,000/mm3 9. Bilirubin less than 1.25 times upper limit of normal (ULN) 10. Creatinine less than 1.25 times ULN 11. No other serious disabling diseases contraindicating primary cytoreductive surgery or primary platin-based chemotherapy 12. No other prior primary malignancies except carcinoma in situ of the cervix or basal cell carcinoma of the skin 13. No psychological, familial, sociological, or geographical condition potentially preventing protocol compliance or follow-up 14. Aged between 18 - 50 years
Exclusion criteria
Exclusion criteria: 1. No other serious disabling diseases contraindicating for primary cytoreductive surgery or primary platin based chemotherapy 2. No other prior primary malignancies, except for carcinoma in situ of the cervix and basal carcinoma of the skin 3. Absence of any psychological, familial, sociological or geographical condition potentially preventing compliance with the study protocol and follow-up schedule
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall crude survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Progression-free survival 2. Quality of life according to the EORTC questionnaire QLQ-C30 3. To assess the different treatment complications in relation to treatment arm | — |
Countries
Argentina, Austria, Belgium, Canada, Denmark, France, Germany, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed