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

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
lomustine
procarbazine hydrochloride
vincristine sulfate
radiation therapy
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring recurrent adult brain tumor, adult anaplastic oligodendroglioma, adult mixed glioma

Eligibility Criteria

16 Years - 69 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaiser Franz Josef Hospital
  • Academisch Ziekenhuis der Vrije Universiteit Brussel
  • Hopital Universitaire Erasme
  • Hopital de Jolimont
  • U.Z. Gasthuisberg
  • Turku University Central Hospital
  • Centre Hospitalier Regional de Lille
  • CHU de la Timone
  • CHU de Nancy - Hopital Neurologique
  • CRLCC Nantes - Atlantique
  • Hopital Pasteur
  • Centre Antoine Lacassagne
  • C.H.R. de Nimes - Hopital Caremeau
  • CHU Pitie-Salpetriere
  • Centre Eugene Marquis
  • Institut Gustave Roussy
  • Neurologische Klinik der Henriettenstiftung
  • Klinikum der Friedrich-Schiller Universitaet Jena
  • National Institute of Neurosurgery
  • Azienda Ospedaliera di Padova
  • Universita di Padova
  • Medisch Centrum Haaglanden
  • Vrije Universiteit Medisch Centrum
  • Academisch Medisch Centrum
  • Academisch Ziekenhuis Groningen
  • University Medical Center Nijmegen
  • Rotterdam Cancer Institute
  • St. Elisabeth Ziekenhuis
  • Dr. Bernard Verbeeten Instituut
  • Academisch Ziekenhuis Utrecht
  • Instituto Portugues de Oncologia de Francisco Gentil
  • University Hospital of Linkoping
  • Umea Universitet
  • Centre Hospitalier Universitaire Vaudois
  • Nottingham General Hospital
  • Nottingham City Hospital NHS Trust
  • Queen's Medical Centre
  • Royal South Hants Hospital
  • Southampton General Hospital
  • Royal Marsden Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
July 6, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Collaborators
Medical Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT00002840
Brief Title
Radiation Therapy With and Without Combination Chemotherapy in Patients With Resected Anaplastic Oligodendroglioma
Official Title
PHASE III STUDY OF ADJUVANT PROCARBAZINE, CCNU AND VINCRISTINE CHEMOTHERAPY IN PATIENTS WITH HIGHLY ANAPLASTIC OLIGODENDROGLIOMA
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
August 1996 (undefined)
Primary Completion Date
March 2002 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Collaborators
Medical Research Council

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
recurrent adult brain tumor, adult anaplastic oligodendroglioma, adult mixed glioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
lomustine
Intervention Type
Drug
Intervention Name(s)
procarbazine hydrochloride
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin J. van Den Bent, MD
Organizational Affiliation
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Kaiser Franz Josef Hospital
City
Vienna (Wien)
ZIP/Postal Code
A-1100
Country
Austria
Facility Name
Academisch Ziekenhuis der Vrije Universiteit Brussel
City
Brussels (Bruxelles)
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Hopital Universitaire Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Hopital de Jolimont
City
Haine Saint Paul
ZIP/Postal Code
7100
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Turku University Central Hospital
City
Turku
ZIP/Postal Code
FIN-2-0521
Country
Finland
Facility Name
Centre Hospitalier Regional de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
CHU de Nancy - Hopital Neurologique
City
Nancy
ZIP/Postal Code
54035
Country
France
Facility Name
CRLCC Nantes - Atlantique
City
Nantes-Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Hopital Pasteur
City
Nice
ZIP/Postal Code
06002
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
C.H.R. de Nimes - Hopital Caremeau
City
Nimes
ZIP/Postal Code
30000
Country
France
Facility Name
CHU Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35064
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France
Facility Name
Neurologische Klinik der Henriettenstiftung
City
Hannover
ZIP/Postal Code
D-30559
Country
Germany
Facility Name
Klinikum der Friedrich-Schiller Universitaet Jena
City
Jena
ZIP/Postal Code
D-07740
Country
Germany
Facility Name
National Institute of Neurosurgery
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Azienda Ospedaliera di Padova
City
Padova (Padua)
ZIP/Postal Code
35128
Country
Italy
Facility Name
Universita di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Medisch Centrum Haaglanden
City
's-Gravenhage (Den Haag, The Hague)
ZIP/Postal Code
2501 CK
Country
Netherlands
Facility Name
Vrije Universiteit Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1001HV
Country
Netherlands
Facility Name
Academisch Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Academisch Ziekenhuis Groningen
City
Groningen
ZIP/Postal Code
9713 EZ
Country
Netherlands
Facility Name
University Medical Center Nijmegen
City
Nijmegen
ZIP/Postal Code
NL-6500 HB
Country
Netherlands
Facility Name
Rotterdam Cancer Institute
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
Facility Name
St. Elisabeth Ziekenhuis
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
Facility Name
Dr. Bernard Verbeeten Instituut
City
Tilburg
ZIP/Postal Code
5042 SB
Country
Netherlands
Facility Name
Academisch Ziekenhuis Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Instituto Portugues de Oncologia de Francisco Gentil
City
Lisbon
ZIP/Postal Code
1093
Country
Portugal
Facility Name
University Hospital of Linkoping
City
Linkoping
ZIP/Postal Code
S-581 85
Country
Sweden
Facility Name
Umea Universitet
City
Umea
ZIP/Postal Code
S-901 85
Country
Sweden
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
Facility Name
Nottingham General Hospital
City
Nottingham
State/Province
England
ZIP/Postal Code
NG1 6HA
Country
United Kingdom
Facility Name
Nottingham City Hospital NHS Trust
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Queen's Medical Centre
City
Nottingham
State/Province
England
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Royal South Hants Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO14 0YG
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

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

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