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Sponsors and Collaborators: |
Medical Research Council European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002895 |
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.
Condition | Intervention | Phase |
---|---|---|
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Procedure: chemotherapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
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 |
Estimated Enrollment: | 1400 |
Study Start Date: | June 1996 |
OBJECTIVES:
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.
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.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer
Prior participation in the following clinical trials is allowed:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Austria | |
Kaiser Franz Josef Hospital | |
Vienna, Austria, A-1100 | |
Belgium | |
Academisch Ziekenhuis der Vrije Universiteit Brussel | |
Brussels, Belgium, 1090 | |
Cazk Groeninghe - Campus Maria's Voorzienigheid | |
Kortrijk, Belgium, B-8500 | |
Institut Jules Bordet | |
Brussels, Belgium, 1000 | |
France | |
Centre Regional Francois Baclesse | |
Caen, France, 14076 | |
Ireland | |
Coombe Women's Hospital | |
Dublin, Ireland, 8 | |
St. James' Hospital | |
Dublin, Ireland, 8 | |
Italy | |
Spedali Civili di Brescia | |
Brescia, Italy, 25124 | |
Netherlands | |
Academisch Medisch Centrum at University of Amsterdam | |
Amsterdam, Netherlands, 1105 AZ | |
Daniel Den Hoed Cancer Center at Erasmus Medical Center | |
Rotterdam, Netherlands, 3008 AE | |
Isala Klinieken - locatie Sophia | |
Zwolle, Netherlands, 8000 GK | |
Leiden University Medical Center | |
Leiden, Netherlands, 2300 RC | |
Leyenburg Ziekenhuis | |
's-Gravenhage, Netherlands, 2545 CH | |
Nijmegen Cancer Center at Radboud University Medical Center | |
Nijmegen, Netherlands, NL-6500 HB | |
University Medical Center Utrecht | |
Utrecht, Netherlands, 3508 GA | |
Portugal | |
Hospitais da Universidade de Coimbra (HUC) | |
Coimbra, Portugal, 3001-301 | |
South Africa | |
Groote Schuur Hospital | |
Cape Town, South Africa, 7925 | |
Spain | |
Hospital Universitario 12 de Octubre | |
Madrid, Spain, 28041 | |
Hospital Universitario San Carlos | |
Madrid, Spain, 28040 | |
Institut d'Oncologia Corachan | |
Barcelona, Spain, 08017 | |
United Kingdom, England | |
Mount Vernon Cancer Centre at Mount Vernon Hospital | |
Northwood, England, United Kingdom, HA6 2RN |
Investigator: | Gordon J.S. Rustin, MD | Mount Vernon Cancer Centre at Mount Vernon Hospital |
Investigator: | M. E.L. van der Burg, MD, PhD | University Medical Center Rotterdam at Erasmus Medical Center |
Study ID Numbers: | CDR0000065218, MRC-OV05, EORTC-55955, ISRCTN87786644 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002895 |
Health Authority: | United States: Federal Government |
recurrent ovarian epithelial cancer peritoneal cavity cancer fallopian tube cancer |
Ovarian cancer Digestive System Neoplasms Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer Abdominal Neoplasms Fallopian Tube Neoplasms |
Dental Caries Recurrence Fallopian Tube Diseases Genital Diseases, Female Digestive System Diseases Peritoneal Diseases Gastrointestinal Neoplasms Endocrinopathy Fallopian tube cancer Peritoneal Neoplasms Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Adnexal Diseases |