ACTRN12606000300572
Completed
Phase 3
An open, randomised controlled phase III clinical trial investigating whether the addition of tamoxifen to cisplatin (or carboplatin) and cyclophosphamide for the treatment of International Federation of Gynecology and Obstetrics (FIGO) Stage III and IV advanced carcinoma of the ovary improves time to disease progression
The Cancer Council Victoria0 sites230 target enrollmentDecember 9, 1994
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Advanced carcinoma of the ovary
- Sponsor
- The Cancer Council Victoria
- Enrollment
- 230
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed advanced epithelial carcinoma of the ovary (FIGO Stage III or IV), excluding tumours of low malignant potential. ECOG performance status 0 to 3\. No previous systemic chemotherapy or radiotherapy. No history of other malignancies apart from skin cancer or adequately treated carcinoma\-in\-situ of the cervix. Adequate bone marrow function, viz. white cell count \> 4\.0 x 10^9/L, platelets \> 100 x 10^9/L. Adequate renal function, viz. serum creatinine \< 0\.15 mmol/L (for patients to be given cisplatin) or creatinine clearance \> 0\.4 ml/sec (for patients to be given carboplatin). Suitable for follow\-up\- Informed consent, according to the Ethics Committee requirements of each institution, must be obtained. Surgery must have been performed within the previous 6 weeks. The dimensions of the largest residual tumour deposit(s) must at the conclusion of primary surgery must be known.
Exclusion Criteria
- •No exclusion criteria
Outcomes
Primary Outcomes
Not specified
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