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

December 3, 2013 updated by: Medical Research Council

A Randomised Trial in Relapsed Ovarian Cancer: Early Treatment Based on CA 125 Levels Alone Vs. Delayed Treatment Based On Conventional Clinical Indicators

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, A-1100
        • Kaiser Franz Josef Hospital
  • Belgium
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Brussels, Belgium, 1090
        • Academisch Ziekenhuis der Vrije Universiteit Brussel
      • Kortrijk, Belgium, B-8500
        • Cazk Groeninghe - Campus Maria's Voorzienigheid
  • France
      • Caen, France, 14076
        • Centre Regional Francois Baclesse
  • Ireland
      • Dublin, Ireland, 8
        • St. James' Hospital
      • Dublin, Ireland, 8
        • Coombe Women's Hospital
  • Italy
      • Brescia, Italy, 25124
        • Spedali Civili di Brescia
  • Netherlands
      • 's-Gravenhage, Netherlands, 2545 CH
        • Leyenburg Ziekenhuis
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum at University of Amsterdam
      • Leiden, Netherlands, 2300 RC
        • Leiden University Medical Center
      • Nijmegen, Netherlands, NL-6500 HB
        • Nijmegen Cancer Center at Radboud University Medical Center
      • Rotterdam, Netherlands, 3008 AE
        • Daniel Den Hoed Cancer Center at Erasmus Medical Center
      • Utrecht, Netherlands, 3508 GA
        • University Medical Center Utrecht
      • Zwolle, Netherlands, 8000 GK
        • Isala Klinieken - locatie Sophia
  • Portugal
      • Coimbra, Portugal, 3001-301
        • Hospitais da Universidade de Coimbra (HUC)
  • South Africa
      • Cape Town, South Africa, 7925
        • Groote Schuur Hospital
  • Spain
      • Barcelona, Spain, 08017
        • Institut d'Oncologia Corachan
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28040
        • Hospital Universitario San Carlos
  • United Kingdom
    • England
      • Northwood, England, United Kingdom, HA6 2RN
        • Mount Vernon Cancer Centre at Mount Vernon Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer

    • Achieved complete remission with normal CA 125 after first-line platinum-containing chemotherapy

  • Prior participation in the following clinical trials is allowed:

    • MRC-ICON2 (carboplatin vs cyclophosphamide, doxorubicin, and cisplatin for advanced disease)
    • MRC-ICON3 (paclitaxel with carboplatin in first-line therapy for advanced disease)
    • MRC-ICON5 (carboplatin and paclitaxel vs triplet and sequential doublet combinations of chemotherapy)
  • No prior participation in MRC-ICON1 (adjuvant chemotherapy for early-stage ovarian cancer)

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No prior or concurrent malignancy within the past 5 years that is likely to preclude study treatment or comparisons except for nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival
Quality of life
Benefit of early chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Research Council

Collaborators

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Gordon J.S. Rustin, MD, Mount Vernon Cancer Centre at Mount Vernon Hospital
  • M. E.L. van der Burg, MD, PhD, University Medical Center Rotterdam at Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1996

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

December 4, 2013

Last Update Submitted That Met QC Criteria

December 3, 2013

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000065218
  • MRC-OV05
  • EORTC-55955
  • ISRCTN87786644

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ovarian Cancer

Clinical Trials on chemotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe