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Clinical Trial RTOG 0834

Title
Phase III trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup trial.
Principal Investigator
Priya Kumthekar
Details
  • Status: Accepting New Patients
  • Study Type: Therapeutic, Treatment
  • Protocol No:.RTOG 0834
Purpose
The purpose of this study is to determine whether the addition of temozolomide treatment to radiotherapy or the addition of temozolomide treatment after completion of radiotherapy will improve the results of the treatment.
Overview
Until recently, brain tumors (anaplastic gliomas) were treated with radiotherapy or with chemotherapy. Previous studies have shown an increased time to regrowth of the tumor but no gain in overall survival time by adding a combination of three chemotherapeutic drugs (procarbazine, lomustine [CCNU], and vincristine—also called PCV)— to radiotherapy. However, PCV chemotherapy causes side effects in many patients. In contrast, another study in a much more malignant brain tumor showed an improved outcome by adding temozolomide chemotherapy during and after radiation. These data are difficult to bring together and have led to patients with these tumors being treated differently at different institutions.
Eligibility
Some of the eligibility criteria include:
  • Participants must be 18 years of age or older.
  • Participants must have newly diagnosed anaplastic glioma (brain tumor).
  • Participants must not have had prior chemotherapy or radiotherapy to the brain.
Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Description of Treatment
Participants will be "randomized" into one of the study groups. Randomization means that participants are put into a group by chance. Neither the participants nor the study doctor can choose the placement of the groups. Participants in group 1 (also called “Arm 1”) will receive radiotherapy alone, with further treatment including chemotherapy if there is tumor growth. Radiotherapy will be delivered over 6-7 weeks. Participants in group 2 (also called “Arm 2”) will receive radiotherapy. In addition, from the first day of radiotherapy until the last day of radiation participants will take temozolomide orally once daily for a maximum of 7 weeks. Participants in group 3 (also called “Arm 3”) will receive radiotherapy. In addition, four weeks after the completion of radiotherapy, participants will receive temozolomide. Participants will take temozolomide once daily for 5 days, every 28 days for up to 12 cycles. This will be for about 12 months. Participants in group 4 (also called “Arm 4”) will receive radiotherapy. In addition, from the first day of radiotherapy until the last day of radiation participants will take temozolomide orally once daily for a maximum of 7 weeks. Four weeks after the completion of radiotherapy, participants will restart temozolomide. Participants will take temozolomide once daily for 5 days, every 28 days for up to 12 cycles. This will be for about 12 months.
Contact
Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
312.695.1102
cancertrials@northwestern.edu

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last updated: 02-Sep-14 09:06 PM

 

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