Proton Beam Therapy for Chordoma Patients
|Chordoma||Radiation: Proton Beam Therapy Radiation: Photon Beam Therapy||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Evaluation of Proton Beam Therapy for Skull Base Chordoma|
- 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.
|Study Start Date:||September 2006|
|Estimated Primary Completion Date:||September 2018 (Final data collection date for primary outcome measure)|
Experimental: 70 Gray (Gy) Proton Beam Therapy
Participants treated to 70 cobalt Gray equivalent (CGE) only (the standard treatment).
Radiation: Proton Beam Therapy
70 Gy once daily at 2 CGE per fraction, no sooner than 2 weeks after last surgery to remove tumor, for between 35-39 treatments.
Experimental: Photon Beam Therapy
Proton beam therapy combined with photon radiation therapy where combination improves final dose distribution.
Radiation: Proton Beam Therapy
70 Gy once daily at 2 CGE per fraction, no sooner than 2 weeks after last surgery to remove tumor, for between 35-39 treatments.Radiation: Photon Beam Therapy
Photon beam therapy once daily, no sooner than 2 weeks after last surgery to remove tumor, for 35-39 treatments.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00496119
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||David Grosshans, MD, PHD||M.D. Anderson Cancer Center|