Trials / Unknown
UnknownNCT00002477
Adjuvant Chemotherapy Compared With Observation in Treating Patients With Resected Early Stage Ovarian Epithelial Cancer
Phase III Randomized Study of Adjuvant Therapy With a Platinum-Containing Regimen (e.g., CBDCA or CAP: CTX/DOX/CDDP) vs No Adjuvant Therapy in Patients With Fully Resected Early Stage Ovarian Cancer
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Medical Research Council · Other Government
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of adjuvant therapy using platinum-based chemotherapy drugs with no adjuvant therapy in treating patients with early stage invasive ovarian epithelial cancer.
Detailed description
OBJECTIVES: I. Determine whether adjuvant chemotherapy with a platinum-containing regimen (e.g., carboplatin or CAP: cyclophosphamide/doxorubicin/cisplatin) prolongs survival in patients with early stage ovarian cancer compared to those receiving no adjuvant treatment. OUTLINE: Randomized study. Patients are randomized to Arm I or II; treatment should begin within 6 weeks of surgery. Regimens listed in Arm I are recommended, but other platinum-containing regimens are allowed provided the doses at a minimum meet those listed below. Arm I: Single-agent Chemotherapy or 3-Drug Combination Chemotherapy. Carboplatin, CBDCA, NSC-241240; or CAP: Cyclophosphamide, CTX, NSC-26271; Doxorubicin, DOX, NSC-123127; Cisplatin, CDDP, NSC-119875. Arm II: Observation. No adjuvant therapy. PROJECTED ACCRUAL: A maximum of 2,000 patients will be randomized.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | carboplatin | |
| DRUG | cisplatin | |
| DRUG | cyclophosphamide | |
| DRUG | doxorubicin hydrochloride |
Timeline
- Start date
- 1991-04-01
- First posted
- 2004-05-26
- Last updated
- 2013-12-18
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT00002477. Inclusion in this directory is not an endorsement.