Chemotherapy With or Without Surgery in Treating Patients With Stage II or Stage III Ovarian Cancer

Phase 3

Completed

• Conditions: Ovarian Cancer

• Registration Number: NCT00003695
• Lead Sponsor: Medical Research Council

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with surgery may kill more tumor cells. It is not yet known whether chemotherapy plus surgery is more effective than chemotherapy alone in treating patients with stage II or stage III ovarian cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with or without surgery in treating patients with stage II or stage III ovarian cancer.

Detailed Description

OBJECTIVES: I. Determine the impact of interval debulking surgery, in terms of survival, disease-free survival, and quality of life, in patients with newly diagnosed stage II or III ovarian cancer and residual macroscopic disease greater than 1 cm after primary surgery.

OUTLINE: This is a randomized study of debulking surgery with concurrent chemotherapy. Patients are randomized to receive chemotherapy alone (arm I) or chemotherapy and interval debulking surgery (arm II). Arm I: Patients receive six courses of platinum-based chemotherapy at intervals of 3 weeks. Arm II: Patients receive three courses of platinum-based chemotherapy at intervals of 3 weeks. In the absence of disease progression, patients undergo interval debulking surgery approximately 21 days after initiation of the third course of chemotherapy. Surgery is then immediately followed by three additional courses of platinum-based chemotherapy. Patients are followed at 6 months after randomization, then every 3 months for the remainder of the first 2 years, then every 6 months for the following 3 years, and then annually thereafter. Quality of life is assessed prior to randomization and before the fourth course of chemotherapy, and then at follow-up visits at 6 months and 1, 2, and 3 years.

PROJECTED ACCRUAL: There will be 1,000 patients accrued into this study.

Study Timeline

• Study Start: 1998-05
• Study First Submitted: 1999-11-01
• Study Completion: 2001-01
• Study First Submitted QC: 2004-03-12
• Study First Posted: 2004-03-15
• Status Verified: 2007-05
• Last Update Submitted: 2013-12-03
• Last Update Posted: 2013-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Saint Bartholomew's Hospital; 🇬🇧 London, England, United Kingdom