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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002895
• Other study ID #: CDR0000065218
• Secondary ID: MRC-OV05EORTC-55
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: December 3, 2013
• Start date: June 1996
• Est. completion date: October 2010

Study information

• Verified date: September 2005
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1400
• Est. completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer

Intervention

Drug:
• chemotherapy

Locations

Country	Name	City	State
Austria	Kaiser Franz Josef Hospital	Vienna
Belgium	Academisch Ziekenhuis der Vrije Universiteit Brussel	Brussels
Belgium	Institut Jules Bordet	Brussels
Belgium	Cazk Groeninghe - Campus Maria's Voorzienigheid	Kortrijk
France	Centre Regional Francois Baclesse	Caen
Ireland	Coombe Women's Hospital	Dublin
Ireland	St. James' Hospital	Dublin
Italy	Spedali Civili di Brescia	Brescia
Netherlands	Leyenburg Ziekenhuis	's-Gravenhage
Netherlands	Academisch Medisch Centrum at University of Amsterdam	Amsterdam
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Nijmegen Cancer Center at Radboud University Medical Center	Nijmegen
Netherlands	Daniel Den Hoed Cancer Center at Erasmus Medical Center	Rotterdam
Netherlands	University Medical Center Utrecht	Utrecht
Netherlands	Isala Klinieken - locatie Sophia	Zwolle
Portugal	Hospitais da Universidade de Coimbra (HUC)	Coimbra
South Africa	Groote Schuur Hospital	Cape Town
Spain	Institut d'Oncologia Corachan	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario San Carlos	Madrid
United Kingdom	Mount Vernon Cancer Centre at Mount Vernon Hospital	Northwood	England

Sponsors (2)

Lead Sponsor	Collaborator
Medical Research Council	European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Ireland,  Italy,  Netherlands,  Portugal,  South Africa,  Spain,  United Kingdom, 

References & Publications (3)

Markman M, Petersen J, Belland A, Burg K. CA-125 monitoring in ovarian cancer: patient survey responses to the results of the MRC/EORTC CA-125 Surveillance Trial. Oncology. 2010;78(1):1-2. doi: 10.1159/000292352. Epub 2010 Mar 6. — View Citation

Rustin GJ, van der Burg ME, Griffin CL, Guthrie D, Lamont A, Jayson GC, Kristensen G, Mediola C, Coens C, Qian W, Parmar MK, Swart AM; MRC OV05; EORTC 55955 investigators. Early versus delayed treatment of relapsed ovarian cancer (MRC OV05/EORTC 55955): a — View Citation

Rustin GJ, van der Burg ME: A randomized trial in ovarian cancer (OC) of early treatment of relapse based on CA125 level alone versus delayed treatment based on conventional clinical indicators (MRC OV05/EORTC 55955 trials). [Abstract] J Clin Oncol 27 (Su

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Benefit of early chemotherapy			No
Primary	Overall survival			No
Primary	Quality of life			No