Proton Radiation for the Treatment of Pediatric Bone and Non-Rhabdomyosarcoma Soft Tissue Sarcomas

Not Applicable

Active, not recruiting

• Conditions: Bone Sarcoma; Non-rhabdomyosarcoma Soft Tissue Sarcoma
• Interventions: Radiation: Proton Beam Radiation

• Registration Number: NCT00592293
• Lead Sponsor: Massachusetts General Hospital

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 Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-12-28
• Study First Submitted QC: 2007-12-28
• Study First Posted: 2008-01-14
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-05
• Last Update Posted: 2023-01-09
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Biopsy proven 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Proton Beam Radiation	Proton Beam Radiation	Proton Beam Radiation

Primary Outcome Measures

Name	Time	Method
Local Control	5 years	Rates of local control using proton radiotherapy.
Acute and late toxicities	5 years	Assess frequency and severity of morbidities from irradiation using proton beam therapy in this patient population.

Secondary Outcome Measures

Name	Time	Method
Dosimetric Comparison	5 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.

Trial Locations

Locations (2)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States