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

This study is currently recruiting participants.

Verified by Massachusetts General Hospital, January 2009

First Received: December 28, 2007 Last Updated: January 29, 2009 History of Changes

Sponsors and Collaborators:	Massachusetts General Hospital Brigham and Women's Hospital Children's Hospital Boston Dana-Farber Cancer Institute National Institutes of Health (NIH)
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00592293

Purpose

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	Intervention	Phase
Non-Rhabdomyosarcoma Soft Tissue Sarcoma Bone Sarcoma	Radiation: Proton Beam Radiation	Phase II

MedlinePlus related topics: Cancer Radiation Therapy Soft Tissue Sarcoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Proton Radiation for the Treatment of Pediatric Bone and Non-Rhabdomyosarcoma Soft Tissue Sarcomas

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

To assess the acute and late morbidities from irradiation using proton beam therapy in this patient population. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
To monitor the rates of local control using proton radiotherapy. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare the 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. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	September 2006
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

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.

Eligibility

Ages Eligible for Study:	up to 30 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592293

Contacts

Contact: Torunn Yock, MD	617-724-1836
Contact: Barbara Winrich		bwinrich@partners.org

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Torunn Yock, MD
Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Karen Marcus, MD

Sponsors and Collaborators

Massachusetts General Hospital

Brigham and Women's Hospital

Children's Hospital Boston

Dana-Farber Cancer Institute

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Torunn Yock, MD

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Massachusetts General Hospital ( Torunn Yock, MD )
Study ID Numbers:	05-326
Study First Received:	December 28, 2007
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00592293 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

proton beam radiation

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue
Soft Tissue Sarcomas
Malignant Mesenchymal Tumor
Sarcoma

Additional relevant MeSH terms:

Neoplasms, Connective and Soft Tissue
Neoplasms
Neoplasms by Histologic Type
Sarcoma

ClinicalTrials.gov processed this record on May 07, 2009