Clinical trial NCT00002620: Radiation Therapy in Treating Patients With Brain Cancer
Official title: EFFECT OF DIBROMODULCITOL PLUS BCNU ON FREE INTERVAL AND SURVIVAL OF PATIENTS WITH SUPRATENTORIAL MALIGNANT BRAIN GLIOMAS, A PHASE III TYPE STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Brain and Central Nervous System Tumors
Keywords: adult anaplastic astrocytoma
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2004-07-19
Enrollment: 212
Sex: ALL
Minimum age (years): 16
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 patients with anaplastic astrocytomas.

PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy in treating patients with anaplastic astrocytomas.

Detailed description: OBJECTIVES: I. Compare the disease-free interval and survival in patients with supratentorial malignant brain gliomas randomized to radiotherapy alone vs. radiotherapy plus radiosensitization with mitolactol (DBD) followed by DBD and carmustine.

OUTLINE: Randomized study. Group I: Radiotherapy. External-beam cranial irradiation with megavoltage equipment. Group II: Radiotherapy with Radiosensitization followed by Maintenance Chemotherapy. Radiotherapy as in Group I; with Mitolactol, DBD, NSC-104800; followed by DBD; Carmustine, BCNU, NSC-409962.

PROJECTED ACCRUAL: A total of 212 patients will be entered over more than 3 years.

Eligibility criteria: DISEASE CHARACTERISTICS: Histologically confirmed anaplastic astrocytoma Standard maximum resection or stereotactic biopsy required within 4 weeks prior to therapy

PATIENT CHARACTERISTICS: Age: Over 16 Performance status: ECOG/ZUBROD/WHO 0-2 Life expectancy: At least 8 weeks Hematopoietic: WBC greater than 4,000 Platelets greater than 100,000 Hematocrit greater than 30% Hepatic: Bilirubin less than 2 mg/dl Renal: Creatinine less than 1.5 mg/dl Creatinine clearance greater than 70 ml/min BUN less than 40 mg/dl Other: No major medical illness

PRIOR CONCURRENT THERAPY: No anticancer drugs between surgery and protocol treatment No steroids after 10 days following surgery (may be resumed occasionally during radiotherapy)

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: Charleroi
country: Belgium
facility: Hopital Civil de Charleroi
city: Liege (Luik)
country: Belgium
facility: Centre Hospitalier Regional de la Citadell
city: Hannover
country: Germany
facility: Neurologische Klinik der Henriettenstiftung
city: Treviso
country: Italy
facility: Regional Hospital Treviso
city: Rotterdam
country: Netherlands
facility: Rotterdam Cancer Institute
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: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital NHS Trust
state: England
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: England
Study officials:
affiliation: Erasme University Hospital
name: J. Hildebrand, MD
role: STUDY_CHAIR
References:
citation: Hildebrand J, Gorlia T, Kros JM, Afra D, Frenay M, Omuro A, Stupp R, Lacombe D, Allgeier A, van den Bent MJ; EORTC Brain Tumour Group investigators. Adjuvant dibromodulcitol and BCNU chemotherapy in anaplastic astrocytoma: results of a randomised European Organisation for Research and Treatment of Cancer phase III study (EORTC study 26882). Eur J Cancer. 2008 Jun;44(9):1210-6. doi: 10.1016/j.ejca.2007.12.005. Epub 2008 Jan 14.
citation: Hildebrand J, Sahmoud T, Mignolet F, Brucher JM, Afra D. Adjuvant therapy with dibromodulcitol and BCNU increases survival of adults with malignant gliomas. EORTC Brain Tumor Group. Neurology. 1994 Aug;44(8):1479-83. doi: 10.1212/wnl.44.8.1479.