Early Chemotherapy Based on CA 125 Level Alone Compared With Delayed Chemotherapy in Treating Patients With Recurrent Ovarian Epithelial , Fallopian Tube, or Primary Peritoneal Cancer

Phase 3

Completed

• Conditions: Fallopian Tube Cancer; Primary Peritoneal Cavity Cancer; Ovarian Cancer

• Registration Number: NCT00002895
• Lead Sponsor: Medical Research Council

Brief Summary

RATIONALE: It is not yet known if treatment for recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer is more effective if it is begun when blood levels of CA 125 become elevated rather than waiting for other indicators of disease recurrence.

PURPOSE: This randomized phase III trial is studying early chemotherapy based on blood levels of CA 125 alone to see how well it works compared to chemotherapy based on conventional clinical indicators in patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.

Detailed Description

OBJECTIVES:

* Compare the benefit of early chemotherapy based on CA 125 level only vs chemotherapy based on conventional clinical indicators in patients with relapsed ovarian epithelial, fallopian tube, or primary peritoneal cancer.

* Compare the overall survival of patients treated with these regimens.

* Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients whose CA 125 levels rise to more than two times the upper limit of normal are randomized to one of two treatment arms.

* Arm I: The clinician is informed of the initial rise in CA 125 level. A confirmatory test is performed immediately. Within 4 weeks of the initial CA 125 elevation, patients with a second confirmed elevation receive treatment for recurrent disease according to standard local practice. Patients with a normal CA 125 on the confirmatory test receive no treatment until clinically indicated.

* Arm II: The clinician is blinded to the CA 125 results. Patients undergo normal monitoring. When clinically indicated, patients commence treatment according to standard local practice.

Quality of life is assessed at baseline, at each follow-up visit, and, if treatment is instituted, before each chemotherapy course.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 1,400 patients will be accrued for this study.

Study Timeline

• Study Start: 1996-06
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2005-09
• Study Completion: 2010-10
• Last Update Submitted: 2013-12-03
• Last Update Posted: 2013-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life
Benefit of early chemotherapy
Overall survival

Trial Locations

Locations (21)

Kaiser Franz Josef Hospital; 🇦🇹 Vienna, Austria

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Academisch Ziekenhuis der Vrije Universiteit Brussel; 🇧🇪 Brussels, Belgium

Cazk Groeninghe - Campus Maria's Voorzienigheid; 🇧🇪 Kortrijk, Belgium

Centre Regional Francois Baclesse; 🇫🇷 Caen, France

Coombe Women's Hospital; 🇮🇪 Dublin, Ireland

St. James' Hospital; 🇮🇪 Dublin, Ireland

Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

Leyenburg Ziekenhuis; 🇳🇱 's-Gravenhage, Netherlands

Academisch Medisch Centrum at University of Amsterdam; 🇳🇱 Amsterdam, Netherlands

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