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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-24

Study Completion Date

2016-10-31

Brief Summary

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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.

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Detailed Description

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* 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.

Conditions

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Non-rhabdomyosarcoma Soft Tissue Sarcoma Bone Sarcoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Proton Beam Radiation

Group Type EXPERIMENTAL

Proton Beam Radiation

Intervention Type RADIATION

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

Interventions

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Proton Beam Radiation

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

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* 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

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

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No