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

NCT ID: NCT00003695

Last Updated: 2013-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-05-31
• Study Completion Date: 2001-01-31

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

chemotherapy

Intervention Type: DRUG

surgical procedure

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed newly diagnosed stage II or III ovarian epithelial cancer Must be planning to receive platinum-based chemotherapy Must be fit for interval debulking surgery Residual macroscopic disease with longest dimension of largest tumor mass greater than 1 cm in diameter documented at primary surgery or postoperatively by imaging

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No concurrent or prior malignancy likely to interfere with protocol treatments or comparison

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medical Research Council

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Ian Jacobs, MD

Role: STUDY_CHAIR

Elizabeth Garrett Anderson Hospital

Locations

Saint Bartholomew's Hospital

London, England, United Kingdom

Countries

United Kingdom

Other Identifiers

MRC-OV06

Identifier Type: -

Identifier Source: secondary_id

EU-98063

Identifier Type: -

Identifier Source: secondary_id

CDR0000066799

Identifier Type: -

Identifier Source: org_study_id