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Proton RT for the Treatment of Pediatric Rhabdomyosarcoma

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ClinicalTrials.gov Identifier: NCT00592592
Recruitment Status : Recruiting
First Posted : January 14, 2008
Last Update Posted : October 17, 2017
Information provided by (Responsible Party):

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  (Clinical Trial)
Estimated Enrollment : 110 participants
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
Study Start Date : October 2004
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 [ Time Frame: 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 [ Time Frame: 4 years ]
    Frequency and severity of acute side effects from irradiation using proton beam therapy in this patient population.

  2. Dosimetric comparison [ Time Frame: 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 [ Time Frame: 4 years ]
    Rates of local control using proton radiotherapy.

Eligibility Criteria

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00592592

Contact: Torunn Yock, MD 617-724-1836

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         
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Anita Mahajan, MD         
Principal Investigator: Anita Mahajan, MD         
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)
Principal Investigator: Torunn Yock, MD Massachusetts General Hospital
More Information

Additional Information:
Responsible Party: Torunn Yock, MD, Director, Pediatric Radiation Oncology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00592592     History of Changes
Other Study ID Numbers: 04-188
P01CA021239 ( U.S. NIH Grant/Contract )
First Posted: January 14, 2008    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017

Keywords provided by Torunn Yock, MD, Massachusetts General Hospital:
pediatric rhabdomyosarcoma
proton radiation therapy

Additional relevant MeSH terms:
Rhabdomyosarcoma, Embryonal
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type