Proton RT for the Treatment of Pediatric Rhabdomyosarcoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Massachusetts General Hospital
Sponsor:
Collaborators:
M.D. Anderson Cancer Center
Brigham and Women's Hospital
Children's Hospital Boston
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Torunn Yock, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00592592
First received: December 28, 2007
Last updated: April 10, 2014
Last verified: April 2014

December 28, 2007
April 10, 2014
October 2004
June 2015   (final data collection date for primary outcome measure)
Late toxicity [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
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.
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 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00592592 on ClinicalTrials.gov Archive Site
  • Acute toxicity [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    Frequency and severity of acute side effects from irradiation using proton beam therapy in this patient population.
  • Dosimetric comparison [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Rates of local control using proton radiotherapy.
  • To assess acute side effects from irradiation using proton beam therapy in this patient population. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • To monitor the rates of local control using proton radiotherapy. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Proton RT for the Treatment of Pediatric Rhabdomyosarcoma
A Phase II Trial of Proton RT for the Treatment of Pediatric Rhabdomyosarcoma

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.

  • 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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rhabdomyosarcoma
Radiation: Proton Beam Radiation
Once per day, 5 days a week for a total of 4 to 6 weeks.
Experimental: Proton Beam Radiation
Proton Beam Radiation
Intervention: Radiation: Proton Beam Radiation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
June 2016
June 2015   (final data collection date for primary outcome measure)

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.
Both
up to 21 Years
No
Contact: Torunn Yock, MD 617-724-1836
United States
 
NCT00592592
04-188, P01CA021239
Yes
Torunn Yock, MD, Massachusetts General Hospital
Massachusetts General Hospital
  • M.D. Anderson Cancer Center
  • Brigham and Women's Hospital
  • Children's Hospital Boston
  • Dana-Farber Cancer Institute
  • National Institutes of Health (NIH)
  • National Cancer Institute (NCI)
Principal Investigator: Torunn Yock, MD Massachusetts General Hospital
Massachusetts General Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP