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Clinical Trials (PDQ®)

Phase III Randomized Study of the Benefit of Early Chemotherapy Based on CA 125 Level Only Versus Delayed Chemotherapy Based on Conventional Clinical Indicators in Patients With Relapsed Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

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. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosedNot specifiedOtherMRC-OV05
EORTC-55955, ISRCTN87786644, NCT00002895

Objectives

  1. 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.
  2. Compare the overall survival of patients treated with these regimens.
  3. Compare the quality of life of patients treated with these regimens.

Entry Criteria

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)

Prior/Concurrent Therapy:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

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

Expected Enrollment

1400

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

Outcomes

Primary Outcome(s)

Benefit of early chemotherapy
Overall survival
Quality of life

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.

Published Results

Rustin GJ, van der Burg ME, Griffin CL, et al.: Early versus delayed treatment of relapsed ovarian cancer (MRC OV05/EORTC 55955): a randomised trial. Lancet 376 (9747): 1155-63, 2010.[PUBMED Abstract]

Rustin GJ, van der Burg ME: A randomized trial in ovarian cancer (OC) of early treatment of relapse based on CA125 level alone versus delayed treatment based on conventional clinical indicators (MRC OV05/EORTC 55955 trials). [Abstract] J Clin Oncol 27 (Suppl 18): A-1, 2009.

Related Publications

Markman M, Petersen J, Belland A, et al.: CA-125 monitoring in ovarian cancer: patient survey responses to the results of the MRC/EORTC CA-125 Surveillance Trial. Oncology 78 (1): 1-2, 2010.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Medical Research Council Clinical Trials Unit

Gordon Rustin, MD, Study coordinator
Ph: 44-1923-844-190
Email: grustin@nhs.net

European Organization for Research and Treatment of Cancer

M. van der Burg, MD, PhD, Study coordinator
Ph: 31-10-463-4897
Email: m.e.l.vanderburg@erasmusmc.nl

Registry Information
Official Title A Randomised Trial in Relapsed Ovarian Cancer: Early Treatment Based on CA 125 Levels Alone Vs. Delayed Treatment Based On Conventional Clinical Indicators
Trial Start Date 1996-06-01
Registered in ClinicalTrials.gov NCT00002895
Date Submitted to PDQ 1996-06-01
Information Last Verified 2005-09-08

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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