Brief Title
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
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
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Benefit of early chemotherapy
Condition
Fallopian Tube Cancer
Intervention
chemotherapy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
1400
Start Date
June 1996
Completion Date
October 2010
Eligibility 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)
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
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Gordon J.S. Rustin, MD, ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT00002895
Organization ID
CDR0000065218
Secondary IDs
MRC-OV05
Study Sponsor
Medical Research Council
Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Study Sponsor
Gordon J.S. Rustin, MD, , Mount Vernon Cancer Centre at Mount Vernon Hospital
Verification Date
September 2005