Proton Radiation for the Treatment of Pediatric Bone and Non-Rhabdomyosarcoma Soft Tissue Sarcomas
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- Cumulative Incidence (Estimated Percentage of Participants) Who Developed Toxicities Following Radiation Treatment
Study Overview
Brief Summary
The main purpose of this study is to assess the short term and the long term side effects of proton beam radiation for pediatric bone and non-rhabdomyosarcoma soft tissue sarcomas.
Detailed Description
- Participants will receive radiation treatments once per day, 5 days a week for a total of 4 to 6 weeks, depending on how much total dose the tumor requires. The radiation doctor will see the participant once each week to monitor and record any side effects they may have from radiation treatment.
- A special device will be made for each participant to help them hold still during the treatment. This may either be a mask or foam cradle, depending on the area to be treated.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 30 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Biopsy proven Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS) or bone sarcoma
- •Less than or equal to 30 years of age
- •Patients must have been treated with a standardly accepted chemotherapy regimen if chemotherapy is indicated
- •Patients 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, the patient or guardian must be willing to have their outside medical information released in order to track the results of treatment
- •They or their legal guardian must give their informed consent
- •Timing of radiation may be according to concurrent protocol
Exclusion Criteria
- •Co-morbidities that would make the use of radiation too toxic to deliver safely, such as serious local injury of collagen vascular disease
- •Patients who are pregnant
- •Previous treatment with radiation therapy
- •Concurrent adriamycin or gemcitabine chemotherapy is planned, unless on a concurrent protocol
Arms & Interventions
Proton Beam Radiation
Proton Beam Radiation
Intervention: Proton Beam Radiation (Radiation)
Outcomes
Primary Outcomes
Cumulative Incidence (Estimated Percentage of Participants) Who Developed Toxicities Following Radiation Treatment
Time Frame: 5 years from the completion of radiation treatment
Cumulative incidence (percent of participants and 95% confidence intervals) who experienced a grade 3, 4, or 5 late toxicity. Late complications are defined as the delayed effects attributable to radiation which occur \> 90 days following completion of radiation.
Local Control
Time Frame: 5 years from the start of radiation treatment
Rates of local control using proton radiotherapy. Local control is the lack of tumor recurrence in and or near the area where the primary tumor occurred.
Secondary Outcomes
- Dosimetric Comparison(5 years)
- Dosimetric Comparison(5 years)
Investigators
Torunn Yock, MD
Director, Pediatric Radiation Oncology
Massachusetts General Hospital