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Standard Radiation Therapy With or Without Stereotactic Radiation Therapy in Treating Patients With Glioma Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Standard Radiation Therapy With or Without Stereotactic Radiation Therapy in Treating Patients With Glioma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Standard Radiation Therapy With or Without Stereotactic Radiation Therapy in Treating Patients With Glioma Clinical research trials and Standard Radiation Therapy With or Without Stereotactic Radiation Therapy in Treating Patients With Glioma medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Standard Radiation Therapy With or Without Stereotactic Radiation Therapy in Treating Patients With Glioma. Standard Radiation Therapy With or Without Stereotactic Radiation Therapy in Treating Patients With Glioma Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Standard Radiation Therapy With or Without Stereotactic Radiation Therapy in Treating Patients With Glioma clinical trial. Participants frequently get the best healthcare available for their Standard Radiation Therapy With or Without Stereotactic Radiation Therapy in Treating Patients With Glioma condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Standard Radiation Therapy With or Without Stereotactic Radiation Therapy in Treating Patients With Glioma  Standard Radiation Therapy With or Without Stereotactic Radiation Therapy in Treating Patients With Glioma
Standard Radiation Therapy With or Without Stereotactic Radiation Therapy in Treating Patients With Glioma
For Condition: adult anaplastic astrocytoma,adult glioblastoma multiforme
Status: No longer recruiting
Sponsor(s): EORTC Radiotherapy Cooperative Group ,
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/65 Years
Genders:
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BrigittaBaumert, Study Chair, EORTC Radiotherapy Cooperative Group
Centre Antoine Lacassagne
Nice, , 06189
France
Royal Marsden Hospital
Sutton, England, SM2 5PT
United Kingdom
Medizinische Klinik I
Dresden, , D-01307
Germany
Vrije Universiteit Medisch Centrum
Amsterdam, , 1001HV
Netherlands
Alfred Hospital
Melbourne, Victoria, 3181
Australia
Institut Catala d'Oncologia - Hospital Duran i Reynals
Barcelona, , 08907
Spain
Universitaetsspital
Zurich, , CH-8091
Switzerland
Universitaet Wuerzburg/Hautkrankheiten
Wuerzburg, , D-97080
Germany
Additional Information:
Study ID Numbers: CDR0000067096; EORTC-22972,EORTC-26991,MRC-BR10
Study Start Date: April 1999
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003916
Other Adult Glioblastoma Multiforme Studies:
1. Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma
2. Bortezomib in Treating Patients With Recurrent Glioma
3. Temozolomide Plus Irinotecan in Treating Patients With Recurrent Malignant Glioma
4. Chemotherapy in Treating Patients With Progressive or Recurrent Brain Tumors
5. Antineoplaston Therapy in Treating Patients With Anaplastic Astrocytoma
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Standard Radiation Therapy With or Without Stereotactic Radiation Therapy in Treating Patients With Glioma
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