Clinical trial NCT00592592: Proton Radiation Therapy (RT) for the Treatment of Pediatric Rhabdomyosarcoma
Official title: A Phase II Trial of Proton RT for the Treatment of Pediatric Rhabdomyosarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rhabdomyosarcoma
Keywords: pediatric rhabdomyosarcoma
proton radiation therapy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: M.D. Anderson Cancer Center
name: Brigham and Women's Hospital
name: Boston Children's Hospital
name: Dana-Farber Cancer Institute
name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2008-01-14
Enrollment: 115
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Patients with biopsy proven newly diagnosed rhabdomyosarcoma.
* Patients less than or equal to 30 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.

Primary outcomes:
measure: Cumulative Incidence (Estimated Percent of Participants) With Grade 3 or Higher Toxicity in Follow-up
timeFrame: 5 years from the start of radiation treatment
Secondary outcomes:
measure: Percentage of Participants Who Experienced an Acute Toxicity by Grade
timeFrame: 3 months from radiation treatment
measure: Dosimetric Comparison
timeFrame: 4 years from the start of radiation treatment
measure: Local Control
timeFrame: 5 years from the start of radiation therapy
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Massachusetts General Hospital
name: Torunn Yock, MD
role: PRINCIPAL_INVESTIGATOR
References: