Proton RT for the Treatment of Pediatric Rhabdomyosarcoma
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Proton RT for the Treatment of Pediatric Rhabdomyosarcoma|
- Late toxicity [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]Frequency and severity of late complications from irradiation using proton beam therapy in place of conventional photon beam therapy in pediatric patients with pediatric rhabdomyosarcomas.
- Acute toxicity [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]Frequency and severity of acute side effects from irradiation using proton beam therapy in this patient population.
- Dosimetric comparison [ Time Frame: 4 years ] [ Designated as safety issue: No ]Comparison of Dose distribution to tumor and surrounding normal structures using DVH's generated from the proton plan used to treat the patient and the photon plan generated for comparison purposes.
- Local Control [ Time Frame: 4 years ] [ Designated as safety issue: No ]Rates of local control using proton radiotherapy.
|Study Start Date:||October 2004|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: Proton Beam Radiation
Proton Beam Radiation
Radiation: Proton Beam Radiation
Once per day, 5 days a week for a total of 4 to 6 weeks.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00592592
|Contact: Torunn Yock, MD||617-724-1836|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator: Torunn Yock, MD|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator: Karen Marcus, MD|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Anita Mahajan, MD|
|Principal Investigator: Anita Mahajan, MD|
|Principal Investigator:||Torunn Yock, MD||Massachusetts General Hospital|