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
NCT ID: NCT00002895
Last Updated: 2013-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1400 participants
INTERVENTIONAL
1996-06-30
2010-10-31
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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chemotherapy
Eligibility Criteria
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Inclusion Criteria
* 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
FEMALE
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Medical Research Council
OTHER_GOV
Principal Investigators
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Gordon J.S. Rustin, MD
Role:
Mount Vernon Cancer Centre at Mount Vernon Hospital
M. E.L. van der Burg, MD, PhD
Role:
University Medical Center Rotterdam at Erasmus Medical Center
Locations
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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
Academisch Medisch Centrum at University of Amsterdam
Amsterdam, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Nijmegen Cancer Center at Radboud University Medical Center
Nijmegen, , Netherlands
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Rotterdam, , Netherlands
Leyenburg Ziekenhuis
The Hague, , Netherlands
University Medical Center Utrecht
Utrecht, , Netherlands
Isala Klinieken - locatie Sophia
Zwolle, , Netherlands
Hospitais da Universidade de Coimbra (HUC)
Coimbra, , Portugal
Groote Schuur Hospital
Cape Town, , South Africa
Institut d'Oncologia Corachan
Barcelona, , Spain
Hospital Universitario San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom
Countries
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References
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Markman M, Petersen J, Belland A, Burg K. CA-125 monitoring in ovarian cancer: patient survey responses to the results of the MRC/EORTC CA-125 Surveillance Trial. Oncology. 2010;78(1):1-2. doi: 10.1159/000292352. Epub 2010 Mar 6. No abstract available.
Rustin GJ, van der Burg ME, Griffin CL, Guthrie D, Lamont A, Jayson GC, Kristensen G, Mediola C, Coens C, Qian W, Parmar MK, Swart AM; MRC OV05; EORTC 55955 investigators. Early versus delayed treatment of relapsed ovarian cancer (MRC OV05/EORTC 55955): a randomised trial. Lancet. 2010 Oct 2;376(9747):1155-63. doi: 10.1016/S0140-6736(10)61268-8.
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.
Other Identifiers
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MRC-OV05
Identifier Type: -
Identifier Source: secondary_id
EORTC-55955
Identifier Type: -
Identifier Source: secondary_id
ISRCTN87786644
Identifier Type: -
Identifier Source: secondary_id
CDR0000065218
Identifier Type: -
Identifier Source: org_study_id