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

Bone Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00592293
• Other study ID #: 05-326
• Secondary ID: Other
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2006
• Est. completion date: September 2026

Study information

• Verified date: January 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Sarcoma
• Non-rhabdomyosarcoma Soft Tissue Sarcoma
• Sarcoma

Intervention

Radiation:
• Proton Beam Radiation
Once per day, 5 days a week for a total of 4 to 6 weeks.

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Boston Children's Hospital, Brigham and Women's Hospital, Dana-Farber Cancer Institute, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute and late toxicities	Assess frequency and severity of morbidities from irradiation using proton beam therapy in this patient population.	5 years
Primary	Local Control	Rates of local control using proton radiotherapy.	5 years
Secondary	Dosimetric Comparison	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.	5 years