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
N/A
N/A
Female
Ovarian Cancer
Trial Information
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
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.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically confirmed invasive ovarian cancer of epithelial
origin All tumor resected prior to randomization Uncertain whether immediate chemotherapy
is required
PATIENT CHARACTERISTICS: Age: Any age Performance status: Sufficient to receive
chemotherapy Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
Other: No prior malignancy except nonmelanomatous skin cancer No clear contraindication to
chemotherapy
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery:
Minimum recommended surgical procedures (when possible): Thorough surgical staging Total
hysterectomy/bilateral salpingo-oophorectomy Omentectomy, as follows: Total supracolonic
omentectomy if omentum involved Removal of distal 2 cm or infracolonic omentectomy in the
absence of macroscopic disease
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Christopher J. Williams, DM, FRCP
Investigator Role:
Study Chair
Investigator Affiliation:
Cochrane Cancer Network
Authority:
United States: Federal Government
Study ID:
CDR0000077026
NCT ID:
NCT00002477
Start Date:
April 1991
Completion Date:
Related Keywords:
- Ovarian Cancer
- stage I ovarian epithelial cancer
- stage II ovarian epithelial cancer
- Ovarian Neoplasms
- Neoplasms, Glandular and Epithelial
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