Status: Closed
Activation Date: 2000MAY29
Closing Date: 2002MAR22
Phase: III
Description: A Randomized Phase III Study of Concomitant and Adjuvant Temozolomide and Radiotherapy For Newly Diagnosed Glioblastoma Multiforme
Eligibility: Patients with histologically confirmed newly diagnosed glioblastoma multiforme who have not received prior chemotherapy or radiotherapy; 18 to 70 years of age; WHO performance status < 2; stable, non-increasing dose of corticosteroids; adequate blood counts, liver and kidney function.
Objective: The primary objective of the trial is to test the efficacy of administration of temozolomide as a concomitant and adjuvant treatment to radiotherapy with respect to overall survival compared to radiotherapy alone. The secondary objectives are to compare the two treatment arms with respect to toxicity profile, progression free survival and quality of life.
Participation: Open to member centres
Lay Description: The purpose of this study is to look at whether treatment with temozolomide during and after radiation therapy improves survival and quality of life in patients with a newly diagnosed GBM, compared to radiation therapy alone. Despite these treatments these tumors cannot be cured and they eventually recur. Therefore, new treatments are being investigated to treat patients with GBM.
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| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| BRAIN | CE3 | 168 | 73 | 131 | 149 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| BRAIN | CE3 | 168 | 0 | 0 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| BRAIN | CE3 | 168 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |