Phase II Study of High Dose Intensity Modulated Proton Radiation Treatment +/- Surgical Resection of Sarcomas of the Spine, Sacrum and Base of Skull
- Before beginning radiation therapy, the participants will have a radiation planning
computed tomographic (CT) scan of the tumor site. This is considered standard of care
and the doctor will use the images from this scan to plan the radiation treatment.
- Participants may also receive surgery either before or after the study radiation
treatment. This surgery is also considered standard of care and would be done
regardless of being in the research study.
- The IMPT technique for delivering radiation is for research purposes only. Radiation
treatment to the affected tumor will be given daily, Monday through Friday.
- The following procedures will be performed once a week during treatment: assessment of
nerve, neuromuscular, motor and sensory function by clinical exam and toxicity
- Participants will return for follow-up visits after completion of the radiation
treatment at the following intervals: 6 weeks after completion of treatment, 6 months
after treatment, every 6 months thereafter for 4 years, and then each year after for up
to 15 years.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Local Tumor Control
To define the efficacy or high dose fractionated radiation alone or combined with surgery in achieving local tumor control in patients with base of skull chordomas and patients with spine/sacral chordomas or chondrosarcomas using intensity modulated photon and proton techniques.
Thomas F. DeLaney, MD
Massachusetts General Hospital
United States: Institutional Review Board
|MD Anderson Cancer Center||Houston, Texas 77030-4096|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|