Proton RT for the Treatment of Pediatric Rhabdomyosarcoma
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|ClinicalTrials.gov Identifier: NCT00592592|
Recruitment Status : Recruiting
First Posted : January 14, 2008
Last Update Posted : May 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Rhabdomyosarcoma||Radiation: Proton Beam Radiation||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Proton RT for the Treatment of Pediatric Rhabdomyosarcoma|
|Study Start Date :||October 2004|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
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.
- Late toxicity [ Time Frame: 4 years ]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 ]Frequency and severity of acute side effects from irradiation using proton beam therapy in this patient population.
- Dosimetric comparison [ Time Frame: 4 years ]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 ]Rates of local control using proton radiotherapy.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|