Chemosensitivity Testing to Assign Treatment for Patients With Stage III or Stage IV Ovarian Cancer
RATIONALE: Chemosensitizers may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug.
PURPOSE: Randomized phase III trial to study the effectiveness of chemosensitivity testing to assign treatment for patients with stage III or stage IV ovarian cancer who have undergone surgery.
|Ovarian Cancer||Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: in vitro sensitivity-directed chemotherapy Drug: paclitaxel||Phase 3|
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Randomized Trial on Chemosensitivity Testing in Advanced Primary Ovarian Carcinoma (Phase III)|
|Study Start Date:||July 1996|
|Study Completion Date:||April 2000|
|Primary Completion Date:||April 2000 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine whether the use of a chemosensitivity assay to assign treatment improves the time to progression and response rates of patients with stage III/IV ovarian cancer.
OUTLINE: This is a randomized study. Patients are stratified according to size of tumor after debulking surgery, stage, and Swiss Group for Clinical Cancer Research center where treatment is received. Within 14 days after patients undergo debulking surgery, they are randomized to one of two treatment arms. Arm I: Patients randomized to this arm receive one of six treatment regimens: Regimen A - cisplatin/cyclophosphamide Regimen B - cisplatin/cyclophosphamide/doxorubicin Regimen C - carboplatin Regimen D - carboplatin/cyclophosphamide Regimen E - cisplatin/paclitaxel Regimen F - carboplatin/paclitaxel Arm II: Patients who are randomized to this arm are assigned a treatment regimen based on a chemosensitivity assay of tumor specimens collected after debulking surgery. If no valid assay result is obtained, patients receive carboplatin/cyclophosphamide. Treatment is repeated every 3-4 weeks for a total of 6 courses. Up to 4 more courses may be administered if a partial response is demonstrated. Patients are followed every 3 months for the first 2 years and every 6 months thereafter.
PROJECTED ACCRUAL: Approximately 300 patients will be accrued for this study over 6 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003214
|Aarau, Switzerland, 5001|
|Basel, Switzerland, 4031|
|Office of Walter Weber-Stadelman|
|Basel, Switzerland, CH 4051|
|Basel, Switzerland, CH-4031|
|Bern, Switzerland, CH-3010|
|Hopital Cantonal Universitaire de Geneva|
|Geneva, Switzerland, CH-1211|
|Istituto Oncologico della Svizzera Italiana|
|Lugano, Switzerland, CH-6900|
|Solothurn, Switzerland, 4500|
|City Hospital Triemli|
|Zurich, Switzerland, 8063|
|Zurich, Switzerland, CH-8008|
|Study Chair:||O.R. Kochli, MD||Frauenspital, Basel|