Radiation Therapy, Temozolomide, and Irinotecan in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
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|ClinicalTrials.gov Identifier: NCT00099125|
Recruitment Status : Completed
First Posted : December 9, 2004
Last Update Posted : January 24, 2014
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as temozolomide and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well radiation therapy, temozolomide, and irinotecan work in treating patients with newly diagnosed glioblastoma multiforme.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: irinotecan hydrochloride Drug: temozolomide Procedure: adjuvant therapy Radiation: radiation therapy||Phase 2|
- Compare overall survival of patients with newly diagnosed supratentorial glioblastoma multiforme treated with radiotherapy and temozolomide followed by temozolomide and irinotecan with historical controls from the RTOG database.
- Determine the short- and long-term toxicity of this regimen in these patients.
- Determine progression-free survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Chemoradiotherapy: Patients undergo radiotherapy once daily, 5 days a week, for 6 weeks. Concurrently with radiotherapy, patients receive oral temozolomide once daily, 7 days a week, for 6 weeks.
- Post-radiotherapy chemotherapy: Beginning 4-6 weeks after the completion of chemoradiotherapy, patients receive irinotecan IV on days 1 and 15 and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 157 patients will be accrued for this study within 11 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||170 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Of Radiation Therapy Plus Low Dose Temozolomide Followed By Temozolomide Plus Irinotecan For Glioblastoma Multiforme|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||October 2006|
|Actual Study Completion Date :||November 2013|
Experimental: RT with chemotherapy + post-radiation chemotherapy
Radiation therapy (RT) with concurrent chemotherapy + post-radiation chemotherapy
Drug: irinotecan hydrochloride
Procedure: adjuvant therapy
Radiation: radiation therapy
- Overall survival [ Time Frame: From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months. ]
- Progression-free survival [ Time Frame: From randomization to date of progression, death, or last follow-up. Analysis occurs at the same time as the primary outcome analysis. ]
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): NCT00099125
|Study Chair:||Frank S. Lieberman, MD||University of Pittsburgh|
|Study Chair:||Christina I. Tsien, MD||University of Michigan Rogel Cancer Center|