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 : January 9, 2023
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|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|
|Actual 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||up to 21 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients with biopsy proven newly diagnosed rhabdomyosarcoma.
- Patients less than or equal to 21 years of age.
- Patients must be treated with a standardly accepted chemotherapy regimen.
- May not have metastatic disease unless aged 2-10 with embryonal histology.
- Must be willing to receive follow-up care for a minimum of five years after treatment at MGH and annual visits unless it is too difficult to return to MGH for follow-up care. In that event, they must be willing to have their outside medical information released to us to track the results.
- Timing of radiation must be according to the IRB protocol upon which the patient is treated within either 35 days of last chemotherapy or surgery.
- Life expectancy of less than 2 years.
- Co-morbidities that would make the use of radiation too toxic to deliver safely, such as serious local injury or collagen vascular disease.
- Patients who are pregnant
- Previous treatment with radiation therapy.
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|
|Responsible Party:||Torunn Yock, MD, Director, Pediatric Radiation Oncology, Massachusetts General Hospital|
|Other Study ID Numbers:||
P01CA021239 ( U.S. NIH Grant/Contract )
|First Posted:||January 14, 2008 Key Record Dates|
|Last Update Posted:||January 9, 2023|
|Last Verified:||January 2023|
proton radiation therapy
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type