Proton Radiation Therapy (RT) for the Treatment of Pediatric Rhabdomyosarcoma

NCT00592592 | Completed Results DMC

• 2 other identifiers: 04-188P01CA021239
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 3

Brief Summary

The main purpose of this study is to see if using proton beam radiation therapy instead of photon beam radiation therapy can reduce side effects from radiation treatment for rhabdomyosarcoma. Photon beam radiation is the standard type of radiation for treating most rhabdomyosarcoma and many other types of cancer. Photon beam radiation enters the body and passes through healthy tissue, encounters the tumor, then leaves the body through healthy tissue. A beam of proton radiation enters the body and passes through healthy tissue, encounters tumor, but then stops. This means that less healthy tissue is affected by proton beam radiation than by photon beam radiation.

Conditions

Rhabdomyosarcoma

Keywords

pediatric rhabdomyosarcoma; proton radiation therapy

Outcome Measures

Primary Outcomes (1)

• Cumulative Incidence (Estimated Percent of Participants) With Grade 3 or Higher Toxicity in Follow-up

  Cumulative incidence of participants who experienced a toxicity defined as either grade 3, 4, or 5 after the completion of radiation therapy in pediatric patients with pediatric rhabdomyosarcomas. Late toxicity is scored on a yearly follow-up basis for at least five years. Late toxicities will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. Cumulative incidence is shown at 5 years follow-up.

  5 years from the start of radiation treatment

Secondary Outcomes (3)

• Percentage of Participants Who Experienced an Acute Toxicity by Grade

  3 months from radiation treatment

• Dosimetric Comparison

  4 years from the start of radiation treatment

• Local Control

  5 years from the start of radiation therapy

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:

• Patients with biopsy proven newly diagnosed rhabdomyosarcoma.
• Patients less than or equal to 30 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• Preliminary results of a phase II trial of proton radiotherapy for pediatric rhabdomyosarcoma

MeSH Terms

Conditions

Rhabdomyosarcoma

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Myosarcoma; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

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 1, 2004
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: June 18, 2025
• Results First Posted: June 18, 2025

Record last verified: 2025-06

Locations

US (3)