Completed

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

What is being tested

carmustine

+ chemotherapy

+ mitolactol

DrugRadiation

Who is being recruted

Glioma+10

+ Neoplasms

+ Neoplasms by Histologic Type

Over 16 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: November 1994

See protocol details

Summary

Principal SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC

Last updated: July 2, 2012

Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 1994

Actual date on which the first participant was enrolled.

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.

NCT00002620

Principal SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC

Last updated: July 2, 2012

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

212 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 16 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

GliomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNervous System DiseasesNervous System NeoplasmsNeuroectodermal TumorsNeoplasms, NeuroepithelialAstrocytomaCentral Nervous System Neoplasms

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)

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 14 locations

Kaiser Franz Josef Hospital

Vienna (Wien), AustriaOpen Kaiser Franz Josef Hospital in Google Maps

Hopital Universitaire Erasme

Brussels, Belgium

Academisch Ziekenhuis der Vrije Universiteit Brussel

Brussels (Bruxelles), Belgium

Hopital Civil de Charleroi

Charleroi, Belgium

Completed14 Study Centers