NCT00003916

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for patients with glioma. Stereotactic radiation therapy may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known if standard radiation therapy is more effective when followed by stereotactic radiation therapy. PURPOSE: Randomized phase III trial to compare the effectiveness of standard radiation therapy with or without stereotactic radiation therapy in treating patients who have glioma.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_3

Geographic Reach
7 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1999

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2001

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

February 16, 2004

Completed
Last Updated

September 24, 2012

Status Verified

September 1, 2012

Enrollment Period

2.7 years

First QC Date

November 1, 1999

Last Update Submit

September 20, 2012

Conditions

Brain and Central Nervous System Tumors

Keywords

adult glioblastomaadult anaplastic astrocytomaadult giant cell glioblastomaadult gliosarcoma

Interventions

radiation therapyRADIATION
stereotactic radiosurgeryRADIATION

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven WHO grade III or IV glioma at primary diagnosis that enhance on preoperative imaging Glioblastoma Anaplastic astrocytoma Gliosarcoma Tumor volume no greater than 4.0 cm in maximum diameter on preoperative CT or MRI No prior histology of WHO grade I or II glioma Astrocytoma Oligodendroglioma No brainstem or infratentorial tumor No multifocal glioma Safe to treat tumor stereotactically No close proximity to critical structures, e.g., optic chiasm PATIENT CHARACTERISTICS: Age: 18 to 65 Performance status: WHO 0 or 1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Able to tolerate full course of conventional radiotherapy No prior or concurrent medical condition that would preclude study therapy No prior malignancies within 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No concurrent adjuvant chemotherapy Endocrine therapy: Concurrent steroids allowed Radiotherapy: See Disease Characteristics No prior radiotherapy to the head and neck area No prior radiotherapy to the brain No more than 6 weeks since other prior radiotherapy Surgery: See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (8)

Alfred Hospital

Melbourne, Victoria, 3181, Australia

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Medizinische Klinik I

Dresden, D-01307, Germany

Location

Universitaet Wuerzburg/Hautkrankheiten

Würzburg, D-97080, Germany

Location

Vrije Universiteit Medisch Centrum

Amsterdam, 1001HV, Netherlands

Location

Institut Catala d'Oncologia - Hospital Duran i Reynals

Barcelona, 08907, Spain

Location

Universitaetsspital

Zurich, CH-8091, Switzerland

Location

Royal Marsden Hospital

Sutton, England, SM2 5PT, United Kingdom

Location

Related Publications (2)

  • Baumert BG, Brada M, Bernier J, Kortmann RD, Dehing-Oberije C, Collette L, Davis JB. EORTC 22972-26991/MRC BR10 trial: fractionated stereotactic boost following conventional radiotherapy of high grade gliomas. Clinical and quality-assurance results of the stereotactic boost arm. Radiother Oncol. 2008 Aug;88(2):163-72. doi: 10.1016/j.radonc.2008.03.025. Epub 2008 Apr 30.

    PMID: 18455252RESULT

  • Brada M, Baumert B. Focal fractionated conformal stereotactic boost following conventional radiotherapy of high-grade gliomas: a randomized phase III study. A joint study of the EORTC (22972) and the MRC (BR10). Front Radiat Ther Oncol. 1999;33:241-3. doi: 10.1159/000061233. No abstract available.

    PMID: 10549493RESULT

MeSH Terms

Conditions

Central Nervous System NeoplasmsGlioblastomaAstrocytomaGliosarcoma

Interventions

RadiotherapyRadiosurgery

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

TherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Brigitta Baumert, MD, PhD

    UniversitaetsSpital Zuerich

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

February 16, 2004

Study Start

April 1, 1999

Primary Completion

December 1, 2001

Last Updated

September 24, 2012

Record last verified: 2012-09

Locations

GB(1)FR(1)ES(1)AU(1)DE(2)NL(1)CH(1)