Adjuvant Chemotherapy Compared With Observation in Treating Patients With Resected Early Stage Ovarian Epithelial Cancer
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|ClinicalTrials.gov Identifier: NCT00002477|
Recruitment Status : Unknown
Verified July 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : May 26, 2004
Last Update Posted : December 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||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|
|Study Start Date :||April 1991|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002477
|Cochrane Cancer Network|
|Oxford, England, United Kingdom, OX3 7LF|
|Study Chair:||Christopher J. Williams, DM, FRCP||Cochrane Cancer Network|