NCT00003214

Chemosensitivity Testing to Assign Treatment for Patients With Stage III or Stage IV Ovarian Cancer

Randomized Trial on Chemosensitivity Testing in Advanced Primary Ovarian Carcinoma (Phase III)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Swiss Cancer Institute · Academic / Other
• Sex: Female
• Age: 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	carboplatin
DRUG	cisplatin
DRUG	cyclophosphamide
DRUG	doxorubicin hydrochloride
DRUG	in vitro sensitivity-directed chemotherapy
DRUG	paclitaxel

Timeline

• Start date: 1996-07-01
• Primary completion: 2000-04-01
• Completion: 2000-04-01
• First posted: 2004-08-02
• Last updated: 2019-05-15

Locations

10 sites across 1 country: Switzerland