Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information
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.
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Treatment | Closed | Not specified | Other | MRC-OV05 EORTC-55955, ISRCTN87786644, NCT00002895 |
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.
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
1400A 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 ResultsRustin 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 PublicationsMarkman 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 Lead Organizations
Medical Research Council Clinical Trials Unit
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| Gordon Rustin, MD, Study coordinator | |
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European Organization for Research and Treatment of Cancer
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| M. van der Burg, MD, PhD, Study coordinator | |
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| Registry Information | ||
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| 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 | |
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| Trial Start Date | 1996-06-01 | |
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| Registered in ClinicalTrials.gov | NCT00002895 | |
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| Date Submitted to PDQ | 1996-06-01 | |
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| 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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