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

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

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