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.

Condition	Treatment or Intervention	Phase
adult glioblastoma multiforme adult anaplastic astrocytoma	Procedure: Conventional radiotherapy  Procedure: Stereotactically guided conformal boost radiotherapy	Phase III

Further Study Details: 

OBJECTIVES: I. Compare the effect of adjuvant conventional radiotherapy with or without fractionated stereotactic boost radiotherapy on survival in patients with high grade glioma. II. Compare the quality of life of these patients after these therapies.

PROTOCOL OUTLINE: This is a randomized study. Patients are stratified according to WHO disease grade (III vs IV), center, and age (under 40 vs 40 and over). Patients are randomized to undergo stereotactic radiotherapy or no further treatment after conventional radiotherapy. Patients undergo conventional radiotherapy once or twice a day for up to 6 weeks. Patients randomized to receive additional treatment receive stereotactically guided conformal boost radiotherapy for 4 days, within 4 weeks after completion of conventional radiotherapy. Quality of life is assessed before radiotherapy, then at follow up visits. Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 605 patients will be accrued for this study.

Ages Eligible for Study:  18 Years   -   65 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--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

--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

--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

Australia, Victoria
      Alfred Hospital, Melbourne,  Victoria,  3181,  Australia
France
      Centre Antoine Lacassagne, Nice,  06189,  France
Germany
      Medizinische Klinik I, Dresden,  D-01307,  Germany
      Universitaet Wuerzburg/Hautkrankheiten, Wuerzburg,  D-97080,  Germany
Netherlands
      Vrije Universiteit Medisch Centrum, Amsterdam,  1001HV,  Netherlands
Spain
      Institut Catala d'Oncologia - Hospital Duran i Reynals, Barcelona,  08907,  Spain
Switzerland
      Universitaetsspital, Zurich,  CH-8091,  Switzerland
United Kingdom, England
      Royal Marsden Hospital, Sutton,  England,  SM2 5PT,  United Kingdom

Study chairs or principal investigators

Brigitta Baumert,  Study Chair,  EORTC Radiotherapy Cooperative Group   

Study ID Numbers:  CDR0000067096; EORTC-22972; EORTC-26991; MRC-BR10
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003916
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08