Radiation Therapy and Tamoxifen in Treating Adults With Newly Diagnosed Supratentorial Glioblastoma Multiforme
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|ClinicalTrials.gov Identifier: NCT00006388|
Recruitment Status : Completed
First Posted : February 12, 2004
Last Update Posted : November 17, 2015
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as tamoxifen may make the tumor cells more sensitive to radiation therapy.
PURPOSE: Phase II trial to study the effectiveness of combining radiation therapy with tamoxifen in treating patients who have newly diagnosed supratentorial glioblastoma multiforme.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: tamoxifen citrate Radiation: radiation therapy||Phase 2|
OBJECTIVES: I. Determine whether high-dose tamoxifen initiated at the beginning of conventional radiotherapy improves the median survival time of adults with newly diagnosed, supratentorial glioblastoma multiforme. II. Determine the feasibility and toxicity of high-dose tamoxifen in these patients. III. Determine the overall survival with respect to protein kinase C lab correlates in patients treated with this regimen.
OUTLINE: This is a multicenter study. Beginning within 5 weeks after surgery, patients undergo radiotherapy to the brain 5 days a week for 6 weeks. Patients receive high-dose oral tamoxifen every 6 hours beginning on day 1 of radiotherapy and continuing in the absence of disease progression. Patients are followed every 3 months through year 1, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 6 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||77 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of High Dose Tamoxifen For The Treatment of Newly Diagnosed Supratentorial Glioblastoma Multiforme (GBM)|
|Study Start Date :||December 2000|
|Actual Primary Completion Date :||October 2003|
|Experimental: Radiation plus Tamoxifen||Drug: tamoxifen citrate 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. ]
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): NCT00006388
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|Study Chair:||H. I. Robins, MD, PhD||University of Wisconsin, Madison|