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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00686725 |
The primary purpose of the study is to evaluate the efficacy and safety of early postsurgery temozolomide chemotherapy followed by the standard temozolomide regimen, compared to the standard regimen alone, for the treatment of patients with newly diagnosed glioblastoma multiforme.
Condition | Intervention | Phase |
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Glioblastoma |
Drug: Temozolomide Radiation: Radiotherapy |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Clinical Study of Standard TEMODAL® Regimen Versus Standard Regimen Plus Early Post-Surgery TEMODAL® Chemotherapy in Treatment on Patients With Newly Diagnosed Glioblastoma Multiforme (GBM) |
Estimated Enrollment: | 100 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | May 2011 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm A: Active Comparator
Standard therapy regimen.
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Drug: Temozolomide
For Arm 1, standard treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m2/day, and may be increased to 200 mg/m2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used. For Arm 2, treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for Arm 1.
Radiotherapy will be administered in combination with temozolomide in both treatment arms. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
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Arm B: Experimental
Early postsurgery temozolomide chemotherapy plus standard regimen.
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Drug: Temozolomide
For Arm 1, standard treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m2/day, and may be increased to 200 mg/m2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used. For Arm 2, treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for Arm 1.
Radiotherapy will be administered in combination with temozolomide in both treatment arms. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Only the patients who meet all these criteria can be enrolled in the study:
Laboratory test values must satisfy the following criteria:
Exclusion Criteria:
Patients will not be enrolled if any of the following criteria apply:
Contact: SP Clinical Trial Registry Call Center | 1-888-772-8734 |
China | |
Investigational Site 1 | Recruiting |
Shanghai, China, 200040 | |
Investigational Site 2 | Recruiting |
Beijing, China, 100050 | |
Investigational Site 4 | Recruiting |
Beijing, China, 100730 | |
Investigational Site 10 | Recruiting |
Guangzhou, China, 510515 | |
Investigational Site 7 | Recruiting |
Tianjin, China, 300052 | |
Investigational Site 9 | Recruiting |
Hangzhou, China, 310009 | |
Investigational Site 5 | Recruiting |
Chengdu, China, 610041 |
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P05572 |
Study First Received: | May 27, 2008 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00686725 |
Health Authority: | China: State Food and Drug Administration |
Neuroectodermal Tumors Glioblastoma Glioblastoma multiforme Astrocytoma Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Glioma Temozolomide Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Neoplasms, Nerve Tissue Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Alkylating Agents Pharmacologic Actions |