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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002895
First received: November 1, 1999
Last updated: April 23, 2011
Last verified: September 2005
History of Changes

November 1, 1999
April 23, 2011
June 1996
Not Provided
  • Benefit of early chemotherapy [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00002895 on ClinicalTrials.gov Archive Site
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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
A Randomised Trial in Relapsed Ovarian Cancer: Early Treatment Based on CA 125 Levels Alone Vs. Delayed Treatment Based On Conventional Clinical Indicators

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.

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.
Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
Drug: chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1400
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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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   France,   Ireland,   Italy,   Netherlands,   Portugal,   South Africa,   Spain,   United Kingdom
 
NCT00002895
CDR0000065218, MRC-OV05, EORTC-55955, ISRCTN87786644
Not Provided
Not Provided
Medical Research Council
European Organisation for Research and Treatment of Cancer - EORTC
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
National Cancer Institute (NCI)
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP