Focal Fractionated Conformal Stereotactic Boost Following Conventional Radiotherapy of High Grade Gliomas: A Randomized Phase III Study
18 Years
65 Years
Both
Brain and Central Nervous System Tumors
Trial Information
Focal Fractionated Conformal Stereotactic Boost Following Conventional Radiotherapy of High Grade Gliomas: A Randomized Phase III Study
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.
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.
Inclusion 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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Brigitta Baumert, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
UniversitaetsSpital Zuerich
Authority:
United States: Federal Government
Study ID:
EORTC-22972-26991
NCT ID:
NCT00003916
Start Date:
April 1999
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- adult glioblastoma
- adult anaplastic astrocytoma
- adult giant cell glioblastoma
- adult gliosarcoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
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