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Proton Radiation for the Treatment of Pediatric Bone and Non-Rhabdomyosarcoma Soft Tissue Sarcomas

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Massachusetts General Hospital
Sponsor:
Collaborators:
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:
NCT00592293
First received: December 28, 2007
Last updated: October 16, 2014
Last verified: October 2014

December 28, 2007
October 16, 2014
September 2006
June 2015   (final data collection date for primary outcome measure)
  • Acute and late toxicities [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Assess frequency and severity of morbidities from irradiation using proton beam therapy in this patient population.
  • Local Control [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Rates of local control using proton radiotherapy.
  • To assess the acute and late morbidities from irradiation using proton beam therapy in this patient population. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To monitor the rates of local control using proton radiotherapy. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00592293 on ClinicalTrials.gov Archive Site
Dosimetric Comparison [ Time Frame: 3 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.
To compare the 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: 3 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Proton Radiation for the Treatment of Pediatric Bone and Non-Rhabdomyosarcoma Soft Tissue Sarcomas
Proton Radiation for the Treatment of Pediatric Bone and Non-Rhabdomyosarcoma Soft Tissue Sarcomas

The main purpose of this study is to assess the short term and the long term side effects of proton beam radiation for pediatric bone and non-rhabdomyosarcoma soft tissue sarcomas.

  • Participants will receive radiation treatments once per day, 5 days a week for a total of 4 to 6 weeks, depending on how much total dose the tumor requires. The radiation doctor will see the participant once each week to monitor and record any side effects they may have from radiation treatment.
  • A special device will be made for each participant to help them hold still during the treatment. This may either be a mask or foam cradle, depending on the area to be treated.
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Non-rhabdomyosarcoma Soft Tissue Sarcoma
  • Bone Sarcoma
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
70
June 2018
June 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Biopsy proven NRSTS or bone sarcoma
  • Less than or equal to 30 years of age
  • Patients must have been treated with a standardly accepted chemotherapy regimen if chemotherapy is indicated
  • Patients 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, the patient or guardian must be willing to have their outside medical information released in order to track the results of treatment
  • Timing of radiation may be according to concurrent protocol

Exclusion Criteria:

  • Co-morbidities that would make the use of radiation too toxic to deliver safely, such as serious local injury of collagen vascular disease
  • Patients who are pregnant
  • Previous treatment with radiation therapy
  • Concurrent adriamycin or gemcitabine chemotherapy is planned, unless on a concurrent protocol
Both
up to 30 Years
No
Contact: Torunn Yock, MD 617-724-1836
United States
 
NCT00592293
05-326, Other
Yes
Torunn Yock, MD, Massachusetts General Hospital
Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Children's Hospital Boston
  • Dana-Farber Cancer Institute
  • National Institutes of Health (NIH)
Principal Investigator: Torunn Yock, MD Massachusetts General Hospital
Massachusetts General Hospital
October 2014

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