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.
Primary Purpose: Treatment
Christopher J. Williams, DM, FRCP
Cochrane Cancer Network
United States: Federal Government