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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000300572

Acronym

AO 8971

Enrollment

230

Registered

1994-12-09

Start date

1989-01-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study was for patients who had advanced carcinoma of the ovary. The clinical trial compared carbo/cisplatin and cyclophosphamide chemotherapy alone with carbo/cisplatin and cyclophosphamide chemotherapy with the addition of 5 years of tamoxifen hormone treatment. The combination of carbo/cisplatin and cyclophosphamide was the standard treatment for advanced ovarian cancer. Tamoxifen showed marked activity against ovarian cancer when used on its own but it was not known if adding it to the standard treatment would improve disease free survival. Patients were randomly assigned to one of the treatments to assess if either would be a better treatment for ovarian cancer with acceptable side effects.

Interventions

Arm B: Cisplatin (or carboplatin) + cyclophosphamide + tamoxifen orally 20mg twice a day for 5 years

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Healthy volunteers

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

Outcome results