Ignite Creation Date:
2025-12-24 @ 3:48 PM
Ignite Modification Date:
2025-12-27 @ 2:34 AM
Study NCT ID:
NCT00592592
Status:
COMPLETED
Last Update Posted:
2025-06-18
First Post:
2007-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Proton Radiation Therapy (RT) for the Treatment of Pediatric Rhabdomyosarcoma
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
A Phase II Trial of Proton RT for the Treatment of Pediatric Rhabdomyosarcoma
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P01CA021239 | NIH | None | https://reporter.nih.gov/quic… | View |