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

NCT00592293 | Completed Results DMC

• 2 other identifiers: 05-326Other
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Non-rhabdomyosarcoma Soft Tissue Sarcoma; Bone Sarcoma

Keywords

proton beam radiation

Outcome Measures

Primary Outcomes (2)

• Cumulative Incidence (Estimated Percentage of Participants) Who Developed Toxicities Following 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.

  5 years from the completion of radiation treatment

• Local Control

  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.

  5 years from the start of radiation treatment

Secondary Outcomes (1)

• Dosimetric Comparison

  5 years

Study Arms (1)

Proton Beam Radiation

EXPERIMENTAL

Proton Beam Radiation

Radiation: Proton Beam Radiation

Interventions

Proton Beam Radiation RADIATION

Once per day, 5 days a week for a total of 4 to 6 weeks.

Proton Beam Radiation

Eligibility Criteria

• Age: Up to 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Brigham and Women's Hospital: collaborator
• Boston Children's Hospital: collaborator
• Dana-Farber Cancer Institute: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Sarcoma; Bone Neoplasms

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Torunn Yock, MD
• Organization: Massachusetts General, Hospital

tyock@mgh.harvard.edu

6177262000

Study Officials

• Torunn Yock, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pediatric Radiation Oncology

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: January 14, 2008
• Study Start: October 24, 2006
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: July 3, 2025
• Results First Posted: July 3, 2025

Record last verified: 2025-06

Locations

US (2)