Proton RT for the Treatment of Pediatric Rhabdomyosarcoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00592592|
Recruitment Status : Recruiting
First Posted : January 14, 2008
Last Update Posted : August 18, 2020
|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 :||August 2025|
|Estimated Study Completion Date :||August 2025|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|