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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Boston Children’s Hospital
Dana-Farber Cancer Institute
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Torunn Yock, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00592293
First received: December 28, 2007
Last updated: June 20, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention
Non-rhabdomyosarcoma Soft Tissue Sarcoma Bone Sarcoma Radiation: Proton Beam Radiation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Proton Radiation for the Treatment of Pediatric Bone and Non-Rhabdomyosarcoma Soft Tissue Sarcomas

Resource links provided by NLM:


Further study details as provided by Torunn Yock, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • Acute and late toxicities [ Time Frame: 5 years ]
    Assess frequency and severity of morbidities from irradiation using proton beam therapy in this patient population.

  • Local Control [ Time Frame: 5 years ]
    Rates of local control using proton radiotherapy.


Secondary Outcome Measures:
  • Dosimetric Comparison [ Time Frame: 5 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.


Enrollment: 70
Study Start Date: September 2006
Estimated Study Completion Date: September 2021
Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proton Beam Radiation
Proton Beam Radiation
Radiation: Proton Beam Radiation
Once per day, 5 days a week for a total of 4 to 6 weeks.

Detailed Description:
  • 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.
  Eligibility

Ages Eligible for Study:   up to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • They or their legal guardian must give their informed consent
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592293

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Brigham and Women's Hospital
Boston Children’s Hospital
Dana-Farber Cancer Institute
National Institutes of Health (NIH)
Investigators
Principal Investigator: Torunn Yock, MD Massachusetts General Hospital
  More Information

Responsible Party: Torunn Yock, MD, Director, Pediatric Radiation Oncology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00592293     History of Changes
Other Study ID Numbers: 05-326
Other ( Other Grant/Funding Number: program income on C06 CA059267 )
Study First Received: December 28, 2007
Last Updated: June 20, 2017

Keywords provided by Torunn Yock, MD, Massachusetts General Hospital:
proton beam radiation

Additional relevant MeSH terms:
Sarcoma
Osteosarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on June 22, 2017