Radiation Therapy in Treating Patients With Brain Cancer

Brain and Central Nervous System Tumors Clinical Trial

Official title:

EFFECT OF DIBROMODULCITOL PLUS BCNU ON FREE INTERVAL AND SURVIVAL OF PATIENTS WITH SUPRATENTORIAL MALIGNANT BRAIN GLIOMAS, A PHASE III TYPE STUDY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002620
• Other study ID #: EORTC-26882
• Secondary ID: EORTC-26882
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: June 29, 2012
• Start date: November 1994

Study information

• Verified date: June 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. primary completion date: June 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Drug:
• carmustine

• chemotherapy

• mitolactol

Radiation:
• low-LET cobalt-60 gamma ray therapy

• low-LET photon therapy

Locations

Country	Name	City	State
Austria	Kaiser Franz Josef Hospital	Vienna (Wien)
Belgium	Hopital Universitaire Erasme	Brussels
Belgium	Academisch Ziekenhuis der Vrije Universiteit Brussel	Brussels (Bruxelles)
Belgium	Hopital Civil de Charleroi	Charleroi
Belgium	Centre Hospitalier Regional de la Citadell	Liege (Luik)
Germany	Neurologische Klinik der Henriettenstiftung	Hannover
Italy	Regional Hospital Treviso	Treviso
Netherlands	Rotterdam Cancer Institute	Rotterdam
Netherlands	Dr. Bernard Verbeeten Instituut	Tilburg
Netherlands	Academisch Ziekenhuis Utrecht	Utrecht
Portugal	Instituto Portugues de Oncologia de Francisco Gentil	Lisbon
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
United Kingdom	Nottingham City Hospital NHS Trust	Nottingham	England
United Kingdom	Southampton General Hospital	Southampton	England

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Austria,  Belgium,  Germany,  Italy,  Netherlands,  Portugal,  Switzerland,  United Kingdom, 

References & Publications (2)

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 — View 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. — View Citation