Proton RT for the Treatment of Pediatric Rhabdomyosarcoma

Brief Title

Proton RT for the Treatment of Pediatric Rhabdomyosarcoma

Official Title

A Phase II Trial of Proton RT for the Treatment of Pediatric Rhabdomyosarcoma

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.
    

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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

Late toxicity

Secondary Outcome

 Acute toxicity

Condition

Rhabdomyosarcoma

Intervention

Proton Beam Radiation

Study Arms / Comparison Groups

 Proton Beam Radiation
Description:  Proton Beam Radiation

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Radiation

Estimated Enrollment

110

Start Date

October 2004

Completion Date

August 2025

Primary Completion Date

August 2025

Eligibility 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.
      

Gender

All

Ages

N/A - 21 Years

Accepts Healthy Volunteers

No

Contacts

Torunn Yock, MD, 617-724-1836, 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00592592

Organization ID

04-188

Secondary IDs

P01CA021239

Responsible Party

Principal Investigator

Study Sponsor

Massachusetts General Hospital

Collaborators

 M.D. Anderson Cancer Center

Study Sponsor

Torunn Yock, MD, Principal Investigator, Massachusetts General Hospital


Verification Date

September 2021