Standard Radiation Therapy With or Without Stereotactic Radiation Therapy in Treating Patients With Glioma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00003916|
Recruitment Status : Completed
First Posted : February 16, 2004
Last Update Posted : September 24, 2012
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 or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Radiation: radiation therapy Radiation: stereotactic radiosurgery||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Official Title:||Focal Fractionated Conformal Stereotactic Boost Following Conventional Radiotherapy of High Grade Gliomas: A Randomized Phase III Study|
|Study Start Date :||April 1999|
|Actual Primary Completion Date :||December 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003916
|Melbourne, Victoria, Australia, 3181|
|Centre Antoine Lacassagne|
|Nice, France, 06189|
|Medizinische Klinik I|
|Dresden, Germany, D-01307|
|Wuerzburg, Germany, D-97080|
|Vrije Universiteit Medisch Centrum|
|Amsterdam, Netherlands, 1001HV|
|Institut Catala d'Oncologia - Hospital Duran i Reynals|
|Barcelona, Spain, 08907|
|Zurich, Switzerland, CH-8091|
|Royal Marsden Hospital|
|Sutton, England, United Kingdom, SM2 5PT|
|Study Chair:||Brigitta Baumert, MD, PhD||UniversitaetsSpital Zuerich|