Radiation Therapy With and Without Combination Chemotherapy in Patients With Resected Anaplastic Oligodendroglioma

July 6, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

PHASE III STUDY OF ADJUVANT PROCARBAZINE, CCNU AND VINCRISTINE CHEMOTHERAPY IN PATIENTS WITH HIGHLY ANAPLASTIC OLIGODENDROGLIOMA

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells, and may be an effective treatment for anaplastic oligodendroglioma. Combining combination chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare radiation therapy with and without combination chemotherapy in patients with resected anaplastic oligodendroglioma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Compare survival and time to first progression in patients with anaplastic oligodendroglioma treated with radiotherapy with or without adjuvant procarbazine, lomustine, and vincristine (PCV) following surgical resection. II. Investigate the effect of PCV on quality of life and neurologic function in these patients. III. Determine the toxicity of PCV in these patients. IV. Correlate chromosomal lesions (1p and/or 19q, 9p, p53 loss and mutation, amplification of chromosome 7, or loss of chromosome 10) with progression-free and overall survival in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age, extent of resection, performance status, prior surgery, and participating center. Patients are randomized to one of two treatment arms. Arm I: Within 4-6 weeks after surgery, patients undergo radiotherapy over 7 weeks to the residual tumor volume. Arm II: Patients undergo radiotherapy as in arm I, then begin chemotherapy within 4 weeks after the completion of radiotherapy. Patients receive oral lomustine on day 1, oral procarbazine on days 8-21, and vincristine IV on days 8 and 29. Treatment repeats every 6 weeks in stable and responding patients for a total of 6 courses. Patients with disease recurrence may receive 6 additional courses of chemotherapy as above or another modality at the investigator's discretion. Patients are followed every 3 months for 1 year and then every 6 months for survival.

PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study within 4 years.

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna (Wien), Austria, A-1100
        • Kaiser Franz Josef Hospital
  • Belgium
      • Brussels, Belgium, 1070
        • Hopital Universitaire Erasme
      • Brussels (Bruxelles), Belgium, 1090
        • Academisch Ziekenhuis der Vrije Universiteit Brussel
      • Haine Saint Paul, Belgium, 7100
        • Hôpital de Jolimont
      • Leuven, Belgium, B-3000
        • U.Z. Gasthuisberg
  • Finland
      • Turku, Finland, FIN-2-0521
        • Turku University Central Hospital
  • France
      • Lille, France, 59037
        • Centre Hospitalier Regional de Lille
      • Marseille, France, 13385
        • CHU de la Timone
      • Nancy, France, 54035
        • CHU de Nancy - Hopital Neurologique
      • Nantes-Saint Herblain, France, 44805
        • CRLCC Nantes - Atlantique
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Nice, France, 06002
        • Hôpital Pasteur
      • Nimes, France, 30000
        • C.H.R. de Nimes - Hopital Caremeau
      • Paris, France, 75651
        • CHU Pitié-Salpêtrière
      • Rennes, France, 35064
        • Centre Eugène Marquis
      • Villejuif, France, F-94805
        • Institut Gustave Roussy
  • Germany
      • Hannover, Germany, D-30559
        • Neurologische Klinik der Henriettenstiftung
      • Jena, Germany, D-07740
        • Klinikum der Friedrich-Schiller Universitaet Jena
  • Hungary
      • Budapest, Hungary, 1145
        • National Institute of Neurosurgery
  • Italy
      • Padova, Italy, 35128
        • Universita Di Padova
      • Padova (Padua), Italy, 35128
        • Azienda Ospedaliera di Padova
  • Netherlands
      • 's-Gravenhage (Den Haag, The Hague), Netherlands, 2501 CK
        • Medisch Centrum Haaglanden
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum
      • Amsterdam, Netherlands, 1001HV
        • Vrije Universiteit Medisch Centrum
      • Groningen, Netherlands, 9713 EZ
        • Academisch Ziekenhuis Groningen
      • Nijmegen, Netherlands, NL-6500 HB
        • University Medical Center Nijmegen
      • Rotterdam, Netherlands, 3075 EA
        • Rotterdam Cancer Institute
      • Tilburg, Netherlands, 5022 GC
        • St. Elisabeth Ziekenhuis
      • Tilburg, Netherlands, 5042 SB
        • Dr. Bernard Verbeeten Instituut
      • Utrecht, Netherlands, 3584 CX
        • Academisch Ziekenhuis Utrecht
  • Portugal
      • Lisbon, Portugal, 1093
        • Instituto Portugues de Oncologia de Francisco Gentil
  • Sweden
      • Linkoping, Sweden, S-581 85
        • University Hospital of Linkoping
      • Umea, Sweden, S-901 85
        • Umeå universitet
  • Switzerland
      • Lausanne, Switzerland, CH-1011
        • Centre Hospitalier Universitaire Vaudois
  • United Kingdom
    • England
      • Nottingham, England, United Kingdom, NG7 2UH
        • Queen's Medical Centre
      • Nottingham, England, United Kingdom, NG5 1PB
        • Nottingham City Hospital NHS Trust
      • Nottingham, England, United Kingdom, NG1 6HA
        • Nottingham General Hospital
      • Southampton, England, United Kingdom, SO16 6YD
        • Southampton General Hospital
      • Southampton, England, United Kingdom, SO14 0YG
        • Royal South Hants Hospital
      • Sutton, England, United Kingdom, SM2 5PT
        • Royal Marsden Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 69 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Newly diagnosed oligodendroglioma or oligoastrocytoma (with at least 25% oligodendral elements) Low-grade oligodendroastrocytoma or oligodendroglioma that is recurrent after surgery without radiotherapy is allowed Prior partial or gross total resection of tumor (or biopsy only in case of no further surgical option) required At least 3 of the following histologic anaplastic features: High cellularity Endothelial abnormalities Nuclear abnormalities Necrosis Mitoses

PATIENT CHARACTERISTICS: Age: 16 to 69 Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.4 mg/dL Renal: Creatinine no greater than 1.3 mg/dL Creatinine clearance at least 60 mL/min Other: Not pregnant or nursing Fertile patients must use effective contraception No active or uncontrolled infection No other disease, including malignancy, that would preclude study No neurologic or psychiatric disturbance that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to the skull Surgery: See Disease Characteristics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Collaborators

Medical Research Council

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1996

Primary Completion (ACTUAL)

March 1, 2002

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 21, 2004

First Posted (ESTIMATE)

January 22, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

July 10, 2012

Last Update Submitted That Met QC Criteria

July 6, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-26951
  • MRC-BR11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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