Proton RT for the Treatment of Pediatric Rhabdomyosarcoma

  • STATUS
    Recruiting
  • End date
    Aug 6, 2025
  • participants needed
    110
  • sponsor
    Massachusetts General Hospital
Updated on 23 January 2022
cancer
metastasis
cancer chemotherapy

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.

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.

Details
Condition Rhabdomyosarcoma
Treatment Proton Beam Radiation
Clinical Study IdentifierNCT00592592
SponsorMassachusetts General Hospital
Last Modified on23 January 2022

Eligibility

Yes No Not Sure

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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