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Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme Clinical research trials and Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme healthcare trials happen in many 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 generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme. Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme  Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
For Condition: adult glioblastoma multiforme
Status: No longer recruiting
Sponsor(s): EORTC Brain Tumor Cooperative Group , EORTC Radiotherapy Cooperative Group,National Cancer Institute of Canada
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy is more effective with or without temozolomide for glioblastoma multiforme. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without temozolomide in treating patients who have newly diagnosed glioblastoma multiforme.
Details: OBJECTIVES: I. Compare the efficacy of radiotherapy with or without temozolomide in terms of overall survival in patients with newly diagnosed glioblastoma multiforme. II. Compare the toxicity profiles of these regimens in these patients. III. Compare the progression free survival of these patients treated with these regimens. IV. Compare the quality of life in these patients treated with these regimens. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, age (under 50 vs 50 and over), WHO/ECOG performance status (0-1 vs 2), and extent of surgical resection (biopsy only vs complete or incomplete resection). Patients are randomized to one of two treatment arms. Arm I: Patients undergo radiotherapy 5 days a week for 6 weeks. Arm II: Patients undergo radiotherapy as in arm I concurrently with oral temozolomide daily for 6 weeks. Patients then receive adjuvant oral temozolomide alone on days 1-5 every 28 days for 6 courses beginning 4 weeks after completion of radiotherapy. Quality of life is assessed prior to the study, at week 4 during radiotherapy, at 4 weeks after completion of radiotherapy, at the end of courses 3 and 6 of adjuvant chemotherapy (arm II), and then every 3 months until disease progression. Patients are followed every 3 months until disease progression or death. PROJECTED ACCRUAL: A total of 520 patients (260 per treatment arm) will be accrued for this study within 3.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/70 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed newly diagnosed glioblastoma multiforme by biopsy or surgical resection; Grade IV disease; Initial diagnosis no greater than 6 weeks prior to study --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa; No concurrent biologic therapy; No concurrent immunotherapy - Chemotherapy: No prior chemotherapy; No other concurrent chemotherapy - Endocrine therapy: At least 14 days of prior corticosteroids at a stable dose required; Concurrent corticosteroids allowed - Radiotherapy: No prior radiotherapy; No concurrent stereotactic boost radiotherapy - Surgery: See Disease Characteristics; No concurrent surgery for tumor debulking - Other: No other concurrent investigational drugs --Patient Characteristics-- - Age: 18 to 70 - Performance status: WHO 0-2 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); AST or ALT less than 2.5 times ULN; Alkaline phosphatase less than 2.5 times; ULN No chronic hepatitis B or C - Renal: Creatinine no greater than 1.5 times ULN - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No known HIV infection; No medical condition that would interfere with oral medication intake (e.g., frequent vomiting or partial bowel obstruction); No other prior or concurrent malignancy except surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer; No serious medical, psychological, familial, sociological, or geographical condition that would preclude study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CharlesVecht, Study Chair, EORTC Brain Tumor Cooperative Group
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
Canada
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
British Columbia Cancer Agency - Fraser Valley Cancer Centre
Surrey, British Columbia, V3V 1Z2
Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3
Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2L-4M1
Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, E1C 8X3
Canada
Ottawa Regional Cancer Centre - General Campus
Ottawa, Ontario, K1H 1C4
Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Canada
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Canada
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
Canada
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria, British Columbia, V8R 6V5
Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, A1B 3V6
Canada
Additional Information:
Study ID Numbers: CDR0000068220; EORTC-26981
Study Start Date: July 2000
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006353
Other Adult Glioblastoma Multiforme Studies:
1. Antineoplaston Therapy in Treating Patients With Glioblastoma Multiforme
2. Irinotecan Plus Radiation Therapy Followed By Chemotherapy in Treating Patients With Glioblastoma Multiforme
3. Carmustine Wafers Plus Irinotecan in Treating Patients With Recurrent Supratentorial High Grade Gliomas
4. Radiation Therapy Followed by Bleomycin in Treating Adult Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
5. COL-3 in Treating Patients With Progressive or Recurrent Brain Tumors
Related Studies:
Other adult glioblastoma multiforme Clinical Trials
Other British Columbia Clinical Trials
Other Vancouver Clinical Trials
Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
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