A Phase I Dose Per Fraction Escalation Study of Hypofractionated Intensity-Modulated Radiation Therapy (Hypo-IMRT) Combining With Temozolomide (TMZ) Chemotherapy for Patients With Newly Diagnosed Glioblastoma Multiforme (GBM)
Hypo-IMRT is given in fewer treatments than conventional radiation therapy. This will be a
dose per fraction escalation study. A dose per fraction escalation study means that
successive groups of patients will receive higher doses per fraction of radiation while
keeping the total dose of radiation the same (60 Gy, Gy is a radiation unit). The radiation
dose per fraction will be increased and the numbers of radiation treatments will be
decreased until a fraction dose is reached at which there are unacceptable side effect
compared with possible benefit. Which group you are in will depend on what stage the study
has reached at the time you decide to participate.
This research is being done because with current standard radiation therapy (A total dose of
60 Gy given 2 Gy a day over 6 weeks.) the outcome is very poor. New and more effective
radiation therapy methods are desperately needed for the patients like you with GBM.
In this study, radiation therapy is given together with chemotherapy of Temozolomide.
This study is also designed to monitor the level of some of the known cytokines (specific
proteins in the blood) before and after radiation, and in meantime to screen unknown
proteins in patients' blood before and after radiation therapy. Hopefully, this will provide
us with some clues for future study of monitoring radiation damage, and possibly new
therapeutic approach for patients like you with GBM.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To identify the maximum dose per fraction of IMRT a patient can tolerate while keeping the total radiation dose at 60 Gy, provided concurrently with daily oral temozolomide chemotherapy
To determine the frequency of patients developing >= grade 3 acute and delayed toxicities attributable to radiotherapy. Acute radiotherapy toxicities are defined as those toxicities which occur during and within 30 days from the completion of radiotherapy and delayed toxicity are those developed at least 30 days after the last dose of radiation.
Up to 60 days
Changhu Chen, M.D
University of Colorado, Denver
United States: Institutional Review Board
|University of Colorado Cancer Center||Denver, Colorado 80262|