Radiation Therapy in Treating Patients With Brain Cancer

NCT ID: NCT00002620

Last Updated: 2012-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-11-30

Brief Summary

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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

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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.

Conditions

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Brain and Central Nervous System Tumors

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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carmustine

Intervention Type DRUG

chemotherapy

Intervention Type DRUG

mitolactol

Intervention Type DRUG

low-LET cobalt-60 gamma ray therapy

Intervention Type RADIATION

low-LET photon therapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion 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)
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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J. Hildebrand, MD

Role: STUDY_CHAIR

Erasme University Hospital

Locations

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Kaiser Franz Josef Hospital

Vienna (Wien), , Austria

Site Status

Hopital Universitaire Erasme

Brussels, , Belgium

Site Status

Academisch Ziekenhuis der Vrije Universiteit Brussel

Brussels (Bruxelles), , Belgium

Site Status

Hopital Civil de Charleroi

Charleroi, , Belgium

Site Status

Centre Hospitalier Regional de la Citadell

Liege (Luik), , Belgium

Site Status

Neurologische Klinik der Henriettenstiftung

Hanover, , Germany

Site Status

Regional Hospital Treviso

Treviso, , Italy

Site Status

Rotterdam Cancer Institute

Rotterdam, , Netherlands

Site Status

Dr. Bernard Verbeeten Instituut

Tilburg, , Netherlands

Site Status

Academisch Ziekenhuis Utrecht

Utrecht, , Netherlands

Site Status

Instituto Portugues de Oncologia de Francisco Gentil

Lisbon, , Portugal

Site Status

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Site Status

Nottingham City Hospital NHS Trust

Nottingham, England, United Kingdom

Site Status

Southampton General Hospital

Southampton, England, United Kingdom

Site Status

Countries

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Austria Belgium Germany Italy Netherlands Portugal Switzerland United Kingdom

References

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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.

Reference Type RESULT
PMID: 18248979 (View on PubMed)

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.

Reference Type RESULT
PMID: 8058153 (View on PubMed)

Other Identifiers

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EORTC-26882

Identifier Type: -

Identifier Source: secondary_id

EORTC-26882

Identifier Type: -

Identifier Source: org_study_id

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