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
|ClinicalTrials.gov Identifier: NCT00002895|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 4, 2013
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 or disease||Intervention/treatment||Phase|
|Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer||Drug: chemotherapy||Phase 3|
- 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 (Clinical Trial)|
|Estimated Enrollment :||1400 participants|
|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|
|Study Start Date :||June 1996|
|Actual Study Completion Date :||October 2010|
- Benefit of early chemotherapy
- Overall survival
- Quality of life
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002895
|Kaiser Franz Josef Hospital|
|Vienna, Austria, A-1100|
|Institut Jules Bordet|
|Brussels, Belgium, 1000|
|Academisch Ziekenhuis der Vrije Universiteit Brussel|
|Brussels, Belgium, 1090|
|Cazk Groeninghe - Campus Maria's Voorzienigheid|
|Kortrijk, Belgium, B-8500|
|Centre Regional Francois Baclesse|
|Caen, France, 14076|
|Coombe Women's Hospital|
|Dublin, Ireland, 8|
|St. James' Hospital|
|Dublin, Ireland, 8|
|Spedali Civili di Brescia|
|Brescia, Italy, 25124|
|'s-Gravenhage, Netherlands, 2545 CH|
|Academisch Medisch Centrum at University of Amsterdam|
|Amsterdam, Netherlands, 1105 AZ|
|Leiden University Medical Center|
|Leiden, Netherlands, 2300 RC|
|Nijmegen Cancer Center at Radboud University Medical Center|
|Nijmegen, Netherlands, NL-6500 HB|
|Daniel Den Hoed Cancer Center at Erasmus Medical Center|
|Rotterdam, Netherlands, 3008 AE|
|University Medical Center Utrecht|
|Utrecht, Netherlands, 3508 GA|
|Isala Klinieken - locatie Sophia|
|Zwolle, Netherlands, 8000 GK|
|Hospitais da Universidade de Coimbra (HUC)|
|Coimbra, Portugal, 3001-301|
|Groote Schuur Hospital|
|Cape Town, South Africa, 7925|
|Institut d'Oncologia Corachan|
|Barcelona, Spain, 08017|
|Hospital Universitario San Carlos|
|Madrid, Spain, 28040|
|Hospital Universitario 12 de Octubre|
|Madrid, Spain, 28041|
|Mount Vernon Cancer Centre at Mount Vernon Hospital|
|Northwood, England, United Kingdom, HA6 2RN|
|OverallOfficial:||Gordon J.S. Rustin, MD||Mount Vernon Cancer Centre at Mount Vernon Hospital|
|OverallOfficial:||M. E.L. van der Burg, MD, PhD||University Medical Center Rotterdam at Erasmus Medical Center|