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

NCT00002895 | Completed Phase 3

• 4 other identifiers: CDR0000065218MRC-OV05EORTC-55955ISRCTN87786644
• Study Type: interventional
• Target: 1,400
• Locations: 10 countries
• Sites: 21

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.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancer; primary peritoneal cavity cancer; fallopian tube cancer

Outcome Measures

Primary Outcomes (3)

• Benefit of early chemotherapy

• Overall survival

• Quality of life

Interventions

chemotherapy DRUG

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Medical Research Council: lead
• European Organisation for Research and Treatment of Cancer - EORTC: collaborator

Study Sites (21)

Kaiser Franz Josef Hospital

Vienna, A-1100, Austria

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Academisch Ziekenhuis der Vrije Universiteit Brussel

Brussels, 1090, Belgium

Location

Cazk Groeninghe - Campus Maria's Voorzienigheid

Kortrijk, B-8500, Belgium

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Coombe Women's Hospital

Dublin, 8, Ireland

Location

St. James' Hospital

Dublin, 8, Ireland

Location

Spedali Civili di Brescia

Brescia, 25124, Italy

Location

Academisch Medisch Centrum at University of Amsterdam

Amsterdam, 1105 AZ, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 RC, Netherlands

Location

Nijmegen Cancer Center at Radboud University Medical Center

Nijmegen, NL-6500 HB, Netherlands

Location

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Rotterdam, 3008 AE, Netherlands

Location

Leyenburg Ziekenhuis

The Hague, 2545 CH, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3508 GA, Netherlands

Location

Isala Klinieken - locatie Sophia

Zwolle, 8000 GK, Netherlands

Location

Hospitais da Universidade de Coimbra (HUC)

Coimbra, 3001-301, Portugal

Location

Groote Schuur Hospital

Cape Town, 7925, South Africa

Location

Institut d'Oncologia Corachan

Barcelona, 08017, Spain

Location

Hospital Universitario San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Related 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. No abstract available.

  PMID: 20215782 BACKGROUND

• 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 randomised trial. Lancet. 2010 Oct 2;376(9747):1155-63. doi: 10.1016/S0140-6736(10)61268-8.

  PMID: 20888993 RESULT

• 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 (Suppl 18): A-1, 2009.

  RESULT

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Gordon J.S. Rustin, MD

  Mount Vernon Cancer Centre at Mount Vernon Hospital

• M. E.L. van der Burg, MD, PhD

  University Medical Center Rotterdam at Erasmus Medical Center

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: June 1, 1996
• Study Completion: October 1, 2010
• Last Updated: December 4, 2013

Record last verified: 2005-09

Locations

ES (3); GB (1); AU (1); IT (1); PT (1); ZA (1); IE (2); NL (7); FR (1); BE (3)