Clinical Trial: Proton RT for the Treatment of Pediatric Rhabdomyosarcoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Summary:

  • 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.

Sponsor: Massachusetts General Hospital

Current Primary Outcome: 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.


Original Primary Outcome: 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 ]

Current Secondary Outcome:

  • Acute toxicity [ Time Frame: 4 years ]
    Frequency and severity of acute side effects from irradiation using proton beam therapy in this patient population.
  • 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.
  • Local Control [ Time Frame: 4 years ]
    Rates of local control using proton radiotherapy.


Original Secondary Outcome:

  • To assess acute side effects from irradiation using proton beam therapy in this patient population. [ Time Frame: 4 years ]
  • 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 ]
  • To monitor the rates of local control using proton radiotherapy. [ Time Frame: 4 years ]


Information By: Massachusetts General Hospital

Dates:
Date Received: December 28, 2007
Date Started: October 2004
Date Completion: June 2020
Last Updated: March 2, 2017
Last Verified: March 2017