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PHASE III INGERGROUP STUDY OF RADIOTHERAPY vs TEMOZOLOMIDE ALONE vs RADIOTHERAPY WITH CONCOMITANT AND ADJUVANT TEMOZOLOMIDE (IRB# 23210)
The research in this study is investigational. This study is being carried out under the sponsorship of the North Central Treatment Group (NCCTG).
This research study is being done in people like you who have a certain type of brain tumor, called “anaplastic glioma.” In addition, some of your tumor cells must also be missing parts of chromosomes 1 and 19. These chromosomes are missing parts only in the tumor cells, and are not typically missing in your normal body cells. This type of anaplastic glioma has a more favorable outcome than other types of anaplastic glioma. Standard therapy at this point in time is surgery followed by radiation therapy.
The two main reasons this research study is being done are to see if:
- People have longer survival if they get treatment with the combination of both radiation therapy temozolomide chemotherapy as compared to people who receive treatment with radiation therapy alone
- People treated with temozolomide therapy alone (no radiation therapy) have a better or worse quality of life and mental function than those patients who are treated with either the combination of radiation therapy and temozolomide or radiation therapy alone. Survival will also be monitored in the people getting temozolomide alone
There are three possible treatments that you might get while on this study. You will be "randomized" into one of the study groups (radiation therapy alone [Arm A], radiation therapy alone with temozolomide given during and after radiation therapy [Arm B], and temozolomide alone [Arm C]). Randomization means that you are put into a group by chance (as in a roll of the dice). A computer program will place you in one of the study groups. Neither you nor your doctor can choose the group you will be in.
If you are put on this study during the first portion of the trial, you will have a one in three chance of getting any one of these three treatments. Late in the trial, only the first two treatments will be included in the study. If you are put on this study in the later portions of the trial, you will have a 50/50 chance of getting either radiation therapy alone or radiation therapy along with temozolomide given during and after the radiation therapy.
Surasak Phuphanich, MD, FAAN
Director, Neuro-oncology Program