Proton RT for the Treatment of Pediatric Rhabdomyosarcoma

Rhabdomyosarcoma Clinical Trial

Official title:

A Phase II Trial of Proton RT for the Treatment of Pediatric Rhabdomyosarcoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00592592
• Other study ID #: 04-188
• Secondary ID: P01CA021239
• Status: Recruiting
• Phase: Phase 2
• Start date: October 2004
• Est. completion date: August 2025

Study information

• Verified date: January 2023
• Source: Massachusetts General Hospital
• Contact: Torunn Yock, MD
• Phone: 617-724-1836
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

- A special device is made for each participant to help them hold still during the treatment. This may be in the form of a mask or a custom made foam cradle depending on the area to be treated. - Radiation treatments will be given once per day, 5 days a week for a total of 4 to 6 weeks, depending upon how much total dose the tumor requires. - Participants will be seen once per week by their radiation doctor to monitor health and record any side effects from treatment. - After the radiation treatments are completed, participants will be required to undergo further tests and evaluations for several years following treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

Inclusion Criteria:

• Patients with biopsy proven newly diagnosed rhabdomyosarcoma.
• Patients less than or equal to 21 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Rhabdomyosarcoma

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
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (7)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late toxicity	Frequency and severity of late complications from irradiation using proton beam therapy in place of conventional photon beam therapy in pediatric patients with pediatric rhabdomyosarcomas.	4 years
Secondary	Acute toxicity	Frequency and severity of acute side effects from irradiation using proton beam therapy in this patient population.	4 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.	4 years
Secondary	Local Control	Rates of local control using proton radiotherapy.	4 years

External Links

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