Phase II Evaluation of Proton Beam Therapy for Skull Base Chordoma
Proton therapy is a kind of external beam radiation therapy where protons are directed to a
tumor site. Researchers are trying to determine what level of proton therapy gives the most
benefit without causing toxic side effects. Researchers will also be testing the treatment's
effect.
If your doctor feels it is necessary, the proton beam therapy may be combined with standard
photon therapy.
If you are eligible to take part in this study, you will receive proton beam therapy, and
possibly photon beam, no sooner than 2 weeks after the last surgery to remove the tumor.
You will receive proton beam therapy once a day for about 35 treatments (7 weeks).
Treatment will be given for 5 days in a row each week (except for Saturdays, Sundays and
holidays) at the Proton Center in Houston. The whole process should take up to 1 hour each
day.
This is an investigational study. The proton beam machine used to deliver treatment is
approved by the FDA for patient use. The doses being studied are experimental. About 15
participants will take part in this study. All will be enrolled at M. D. Anderson.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to Local Recurrence
Yearly (Baseline to disease progression)
Yes
David Grosshans, MD, PHD
Principal Investigator
M.D. Anderson Cancer Center
United States: Institutional Review Board
2005-0038
NCT00496119
September 2006
Name | Location |
---|---|
U.T.M.D. Anderson Cancer Center | Houston, Texas 77030 |