Clinical trial NCT00002840: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Brain and Central Nervous System Tumors
Keywords: recurrent adult brain tumor
adult anaplastic oligodendroglioma
adult mixed glioma
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
Collaborators: name: Medical Research Council
First posted: 2004-01-22
Enrollment: 350
Sex: ALL
Minimum age (years): 16
Maximum age (years): 69
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna (Wien)
country: Austria
facility: Kaiser Franz Josef Hospital
city: Brussels (Bruxelles)
country: Belgium
facility: Academisch Ziekenhuis der Vrije Universiteit Brussel
city: Brussels
country: Belgium
facility: Hopital Universitaire Erasme
city: Haine Saint Paul
country: Belgium
facility: Hopital de Jolimont
city: Leuven
country: Belgium
facility: U.Z. Gasthuisberg
city: Turku
country: Finland
facility: Turku University Central Hospital
city: Lille
country: France
facility: Centre Hospitalier Regional de Lille
city: Marseille
country: France
facility: CHU de la Timone
city: Nancy
country: France
facility: CHU de Nancy - Hopital Neurologique
city: Nantes-Saint Herblain
country: France
facility: CRLCC Nantes - Atlantique
city: Nice
country: France
facility: Hopital Pasteur
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Nimes
country: France
facility: C.H.R. de Nimes - Hopital Caremeau
city: Paris
country: France
facility: CHU Pitie-Salpetriere
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Hannover
country: Germany
facility: Neurologische Klinik der Henriettenstiftung
city: Jena
country: Germany
facility: Klinikum der Friedrich-Schiller Universitaet Jena
city: Budapest
country: Hungary
facility: National Institute of Neurosurgery
city: Padova (Padua)
country: Italy
facility: Azienda Ospedaliera di Padova
city: Padova
country: Italy
facility: Universita di Padova
city: 's-Gravenhage (Den Haag, The Hague)
country: Netherlands
facility: Medisch Centrum Haaglanden
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medisch Centrum
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Groningen
country: Netherlands
facility: Academisch Ziekenhuis Groningen
city: Nijmegen
country: Netherlands
facility: University Medical Center Nijmegen
city: Rotterdam
country: Netherlands
facility: Rotterdam Cancer Institute
city: Tilburg
country: Netherlands
facility: St. Elisabeth Ziekenhuis
city: Tilburg
country: Netherlands
facility: Dr. Bernard Verbeeten Instituut
city: Utrecht
country: Netherlands
facility: Academisch Ziekenhuis Utrecht
city: Lisbon
country: Portugal
facility: Instituto Portugues de Oncologia de Francisco Gentil
city: Linkoping
country: Sweden
facility: University Hospital of Linkoping
city: Umea
country: Sweden
facility: Umea Universitet
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Nottingham
country: United Kingdom
facility: Nottingham General Hospital
state: England
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital NHS Trust
state: England
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre
state: England
city: Southampton
country: United Kingdom
facility: Royal South Hants Hospital
state: England
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: England
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
state: England
Study officials:
affiliation: Daniel Den Hoed Cancer Center at Erasmus Medical Center
name: Martin J. van Den Bent, MD
role: STUDY_CHAIR
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