Proton RT for the Treatment of Pediatric Rhabdomyosarcoma

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT00592592
• Collaborator: M.D. Anderson Cancer Center (Other), Brigham and Women's Hospital (Other), Boston Children's Hospital (Other), Dana-Farber Cancer Institute (Other), National Institutes of Health (NIH) (NIH), National Cancer Institute (NCI) (NIH)
• Enrollment: 110
• Locations: 3
• Arm: 1
• Anticipated Duration (Months): 250
• Patients Per Site: 36.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rhabdomyosarcoma	Radiation: Proton Beam Radiation	Phase 2

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 110 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Trial of Proton RT for the Treatment of Pediatric Rhabdomyosarcoma
• Actual Study Start Date: Oct 1, 2004
• Anticipated Primary Completion Date: Aug 1, 2025
• Anticipated Study Completion Date: Aug 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Proton Beam Radiation Proton Beam Radiation	Radiation: Proton Beam Radiation; Once per day, 5 days a week for a total of 4 to 6 weeks.

Outcome Measures

Primary Outcome Measures

1. Late toxicity [4 years]

   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.

Secondary Outcome Measures

1. Acute toxicity [4 years]

   Frequency and severity of acute side effects from irradiation using proton beam therapy in this patient population.

2. Dosimetric comparison [4 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.

3. Local Control [4 years]

   Rates of local control using proton radiotherapy.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
2	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115
3	University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Torunn Yock, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Torunn Yock, MD, Director, Pediatric Radiation Oncology, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT00592592
• Other Study ID Numbers: 04-188; P01CA021239
• First Posted: Jan 14, 2008
• Last Update Posted: Oct 4, 2021
• Last Verified: Sep 1, 2021

• Keywords provided by Torunn Yock, MD, Director, Pediatric Radiation Oncology, Massachusetts General Hospital: pediatric rhabdomyosarcoma; proton radiation therapy
• Additional relevant MeSH terms: Rhabdomyosarcoma

Study Results

No Results Posted as of Oct 4, 2021