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
- Conditions
- Fallopian Tube CancerPrimary Peritoneal Cavity CancerOvarian Cancer
- Registration Number
- NCT00002895
- Lead Sponsor
- Medical Research Council
- Brief Summary
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.
- Detailed Description
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.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1400
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival Quality of life Benefit of early chemotherapy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
Hospital Universitario San Carlos
🇪🇸Madrid, Spain
Kaiser Franz Josef Hospital
🇦🇹Vienna, Austria
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Academisch Ziekenhuis der Vrije Universiteit Brussel
🇧🇪Brussels, Belgium
St. James' Hospital
🇮🇪Dublin, Ireland
Centre Regional Francois Baclesse
🇫🇷Caen, France
Institut Jules Bordet
🇧🇪Brussels, Belgium
Cazk Groeninghe - Campus Maria's Voorzienigheid
🇧🇪Kortrijk, Belgium
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Spedali Civili di Brescia
🇮🇹Brescia, Italy
Hospitais da Universidade de Coimbra (HUC)
🇵🇹Coimbra, Portugal
Coombe Women's Hospital
🇮🇪Dublin, Ireland
Groote Schuur Hospital
🇿🇦Cape Town, South Africa
Institut d'Oncologia Corachan
🇪🇸Barcelona, Spain
Mount Vernon Cancer Centre at Mount Vernon Hospital
🇬🇧Northwood, England, United Kingdom
Daniel Den Hoed Cancer Center at Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
Isala Klinieken - locatie Sophia
🇳🇱Zwolle, Netherlands
Nijmegen Cancer Center at Radboud University Medical Center
🇳🇱Nijmegen, Netherlands
Leyenburg Ziekenhuis
🇳🇱's-Gravenhage, Netherlands
Academisch Medisch Centrum at University of Amsterdam
🇳🇱Amsterdam, Netherlands
University Medical Center Utrecht
🇳🇱Utrecht, Netherlands