Clinical Trial: Proton Beam Therapy for Chordoma Patients
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Phase II Evaluation of Proton Beam Therapy for Skull Base Chordoma
Brief Summary: The goal of this clinical research study is to learn if proton beam therapy, with or without photon beam radiation therapy, is effective in the treatment of skull base chordoma. The safety of this treatment will also be studied.
Detailed Summary:
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 at The University of Texas (UT) MD Anderson Cancer Center (MDACC), 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 MDACC 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 MDACC.
Sponsor: M.D. Anderson Cancer Center
Current Primary Outcome: Time to Local Recurrence [ Time Frame: 1 year after radiation treatments ]
Recurrence classified as "central," "in-field", "marginal," "peripheral," or "distant" depending upon its relationship to the dose distribution on the original treatment plan.
MRI (or CT in case MRI is contraindicated) of the skull base used to document the status of disease in the following categories: 1) stable disease, 2) progressive disease, 3) partial response/complete response. A post-operative MRI (or CT) obtained within 90 days of study registration serves as baseline with annual follow up till disease progression or death for any reason.
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: M.D. Anderson Cancer Center
Dates:
Date Received: July 2, 2007
Date Started: September 2006
Date Completion:
Last Updated: October 18, 2016
Last Verified: October 2016
