Does the addition of tamoxifen to standard chemotherapy improve the time to progression of disease in women with advanced ovarian cancer?

Phase 3

Completed

• Conditions: Advanced carcinoma of the ovary; Cancer - Ovarian and primary peritoneal

• Registration Number: ACTRN12606000300572
• Lead Sponsor: The Cancer Council Victoria

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 1994-12-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 230

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified