NCT00592592

Proton Radiation Therapy (RT) for the Treatment of Pediatric Rhabdomyosarcoma

A Phase II Trial of Proton RT for the Treatment of Pediatric Rhabdomyosarcoma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to see if using proton beam radiation therapy instead of photon beam radiation therapy can reduce side effects from radiation treatment for rhabdomyosarcoma. Photon beam radiation is the standard type of radiation for treating most rhabdomyosarcoma and many other types of cancer. Photon beam radiation enters the body and passes through healthy tissue, encounters the tumor, then leaves the body through healthy tissue. A beam of proton radiation enters the body and passes through healthy tissue, encounters tumor, but then stops. This means that less healthy tissue is affected by proton beam radiation than by photon beam radiation.

Detailed description

* A special device is made for each participant to help them hold still during the treatment. This may be in the form of a mask or a custom made foam cradle depending on the area to be treated. * Radiation treatments will be given once per day, 5 days a week for a total of 4 to 6 weeks, depending upon how much total dose the tumor requires. * Participants will be seen once per week by their radiation doctor to monitor health and record any side effects from treatment. * After the radiation treatments are completed, participants will be required to undergo further tests and evaluations for several years following treatment.

Conditions

• Rhabdomyosarcoma

Interventions

Type	Name	Description
RADIATION	Proton Beam Radiation	Once per day, 5 days a week for a total of 4 to 6 weeks.

Timeline

• Start date: 2004-10-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2008-01-14
• Last updated: 2025-06-18
• Results posted: 2025-06-18

Locations

3 sites across 1 country: United States