Standard Radiation Therapy With or Without Stereotactic Radiation Therapy in Treating Patients With Glioma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00003916
First received: November 1, 1999
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Brain and Central Nervous System Tumors
Radiation: radiation therapy
Radiation: stereotactic radiosurgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Focal Fractionated Conformal Stereotactic Boost Following Conventional Radiotherapy of High Grade Gliomas: A Randomized Phase III Study

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Enrollment: 25
Study Start Date: April 1999
Primary Completion Date: December 2001 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003916

Locations
Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3181
France
Centre Antoine Lacassagne
Nice, France, 06189
Germany
Medizinische Klinik I
Dresden, Germany, D-01307
Universitaet Wuerzburg/Hautkrankheiten
Wuerzburg, Germany, D-97080
Netherlands
Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands, 1001HV
Spain
Institut Catala d'Oncologia - Hospital Duran i Reynals
Barcelona, Spain, 08907
Switzerland
Universitaetsspital
Zurich, Switzerland, CH-8091
United Kingdom
Royal Marsden Hospital
Sutton, England, United Kingdom, SM2 5PT
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Brigitta Baumert, MD, PhD UniversitaetsSpital Zuerich
  More Information

Additional Information:
Publications:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00003916     History of Changes
Other Study ID Numbers: EORTC-22972-26991, EORTC-22972, EORTC-26991, MRC-BR10
Study First Received: November 1, 1999
Last Updated: September 20, 2012
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
adult glioblastoma
adult anaplastic astrocytoma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014