NCT01346124

High Dose Intensity Modulated Proton Radiation Treatment +/- Surgical Resection of Sarcomas of the Spine, Sacrum and Base of Skull

Phase II Study of High Dose Intensity Modulated Proton Radiation Treatment +/- Surgical Resection of Sarcomas of the Spine, Sacrum and Base of Skull

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

There are two types of external radiation treatments; proton beam and photon beam radiation. What type of therapy participants will receive will depend upon the location of their tumor. Standard treatment would involve receiving either proton or photon radiation delivered by a three dimensional (3-D) conformal radiation technique. 3-D conformal radiation therapy is a technique where the beams of radiation used in the treatment are shaped to match the tumor in order to avoid damaging the healthy surrounding tissue. Standard treatment also may include photon radiation delivered by intensity modulated (IMRT) technique. In this research study we are using an investigational technique to deliver proton radiation therapy called intensity modulated proton radiation treatment (IMPT) which is used to target cancer while sparing healthy tissue. With IMPT (and standard IMRT), radiation intensity can be turned down during the treatment. This control over the intensity of the radiation dose has the potential to provide accuracy and allows us to more safely increase the amount of radiation delivered to the tumor. This accuracy may potentially reduce side effects that patients would normally experience with 3-D proton radiation therapy. Surgery is often an important component of the treatment for these tumors and may be integrated with the IMPT.

Detailed description

* 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 assessment. * 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.

Conditions

• Chordoma of Spine
• Chordoma of Sacrum
• Chordoma of Base of Skull
• Chondrosarcoma of the Spine
• Chondrosarcoma of the Sacrum

Interventions

Type	Name	Description
RADIATION	High Dose Intensity Modulated Proton Radiation	Radiation given once a day Monday-Friday

Timeline

• Start date: 2012-12-01
• Primary completion: 2027-06-30
• Completion: 2027-12-31
• First posted: 2011-05-02
• Last updated: 2026-02-11

Locations

2 sites across 1 country: United States