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

Phase 3

Completed

• Conditions: Ovarian Cancer

• Registration Number: NCT00003214
• Lead Sponsor: Swiss Group for Clinical Cancer Research

Brief 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.

Study Timeline

• Study Start: 1996-07
• Study First Submitted: 1999-11-01
• Primary Completion: 2000-04
• Study Completion: 2000-04
• Study First Submitted QC: 2004-07-30
• Study First Posted: 2004-08-02
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-14
• Last Update Posted: 2019-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (10)

Inselspital, Bern; 🇨🇭 Bern, Switzerland

Klinik Hirslanden; 🇨🇭 Zurich, Switzerland

City Hospital Triemli; 🇨🇭 Zurich, Switzerland

Istituto Oncologico della Svizzera Italiana; 🇨🇭 Lugano, Switzerland

Office of Walter Weber-Stadelman; 🇨🇭 Basel, Switzerland

Hopital Cantonal Universitaire de Geneva; 🇨🇭 Geneva, Switzerland

Kantonspital Aarau; 🇨🇭 Aarau, Switzerland

University Hospital; 🇨🇭 Basel, Switzerland

Burgerspital, Solothurn; 🇨🇭 Solothurn, Switzerland

Frauenspital, Basel; 🇨🇭 Basel, Switzerland