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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT00592293
• Collaborator: Brigham and Women's Hospital (Other), Boston Children's Hospital (Other), Dana-Farber Cancer Institute (Other), National Institutes of Health (NIH) (NIH)
• Enrollment: 70
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 239
• Patients Per Site: 35
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-rhabdomyosarcoma Soft Tissue Sarcoma; Bone Sarcoma	Radiation: Proton Beam Radiation	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Proton Radiation for the Treatment of Pediatric Bone and Non-Rhabdomyosarcoma Soft Tissue Sarcomas
• Actual Study Start Date: Oct 1, 2006
• Anticipated Primary Completion Date: Sep 1, 2026
• Anticipated Study Completion Date: Sep 1, 2026

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. Acute and late toxicities [5 years]

   Assess frequency and severity of morbidities from irradiation using proton beam therapy in this patient population.

2. Local Control [5 years]

   Rates of local control using proton radiotherapy.

Secondary Outcome Measures

1. Dosimetric Comparison [5 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

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

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Torunn Yock, MD, Director, Pediatric Radiation Oncology, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT00592293
• Other Study ID Numbers: 05-326; Other
• First Posted: Jan 14, 2008
• Last Update Posted: Oct 1, 2021
• Last Verified: Sep 1, 2021

• Keywords provided by Torunn Yock, MD, Director, Pediatric Radiation Oncology, Massachusetts General Hospital: proton beam radiation
• Additional relevant MeSH terms: Sarcoma

Study Results

No Results Posted as of Oct 1, 2021