RTOG 0834 Phase III trial on Concurrent and Adjuvant Temozolomide chemotherapy in non- 1p/19q deleted anaplastic glioma. The CATNON Intergroup trial.

Objective

The purpose of this study is to determine whether the addition of temozolomide treatment to radiotherapy (concomitant treatment) or the addition of temozolomide treatment after completion of radiotherapy (adjuvant treatment) will improve the results of the treatment. This study will find out what effects, good and/or bad, the addition of temozolomide has when it is given at the same time as radiotherapy, after radiotherapy, or both. (Temzolomide has been approved by the FDA for use in the treatment of newly diagnosed Glioblastoma multiforme (GBM) but has not been approved for the treatment for your type of cancer. It will be referred to as the "study drug".)

IRB Protocol Number

10-0872

Principal Investigator(s)

LAURIE GASPAR

Cancer Trials

• Brain and Nervous System Tumors

Sponsor(s)

RTOG

Contact

MONICA ROBISCHON at 720-848-0661
or MONICA.ROBISCHON@ucdenver.edu

Eligibility and Other Participant Information

What To Expect : Once you are deemed eligible to participate in the study, treatment will begin. Depending on if you are assigned to Group 1, 2, 3 or 4, your treatment may only include radiation therapy, radiation in conjunction with the study drug, the study drug after radiation or both during and after radiation. The total process could take up to 14 months and after treatment is complete, the study doctor will ask you to visit the office for follow-up exams every 3 months indefinitely. // Eligibility criteria include but are not limited to: participants that are 18 years of age and older who have an anaplastic glioma with the chromosome profile required for eligibility.