Proton RT for the Treatment of Pediatric Rhabdomyosarcoma - Full Text View

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:	NCT00592592

Purpose

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	Intervention	Phase
Rhabdomyosarcoma	Radiation: Proton Beam Radiation	Phase II

MedlinePlus related topics: Cancer Radiation Therapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Trial of Proton RT for the Treatment of Pediatric Rhabdomyosarcoma

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

To assess late complications from irradiation using proton beam therapy in place of conventional photon beam therapy in pediatric patients with pediatric rhabdomyosarcomas. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To assess acute side effects from irradiation using proton beam therapy in this patient population. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
To compare 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: 4 years ] [ Designated as safety issue: No ]
To monitor the rates of local control using proton radiotherapy. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	25
Study Start Date:	October 2004
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2011 (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:

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.

Eligibility

Ages Eligible for Study:	up to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592592

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:	04-188
Study First Received:	December 28, 2007
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00592592 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

pediatric rhabdomyosarcoma
proton radiation therapy

Study placed in the following topic categories:

Rhabdomyosarcoma, Embryonal
Neoplasms, Connective and Soft Tissue
Soft Tissue Sarcomas
Malignant Mesenchymal Tumor

Sarcoma
Rhabdomyosarcoma, Childhood
Rhabdomyosarcoma

Additional relevant MeSH terms:

Rhabdomyosarcoma, Embryonal
Neoplasms, Connective and Soft Tissue
Neoplasms, Muscle Tissue
Neoplasms

Neoplasms by Histologic Type
Myosarcoma
Sarcoma
Rhabdomyosarcoma

ClinicalTrials.gov processed this record on May 07, 2009