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Trial record 1 of 1 for:    05-326
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Proton Radiation for the Treatment of Pediatric Bone and Non-Rhabdomyosarcoma Soft Tissue Sarcomas

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ClinicalTrials.gov Identifier: NCT00592293
Recruitment Status : Active, not recruiting
First Posted : January 14, 2008
Last Update Posted : January 9, 2023
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

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Non-rhabdomyosarcoma Soft Tissue Sarcoma Bone Sarcoma Radiation: Proton Beam Radiation Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Proton Radiation for the Treatment of Pediatric Bone and Non-Rhabdomyosarcoma Soft Tissue Sarcomas
Actual Study Start Date : October 2006
Estimated Primary Completion Date : September 2026
Estimated Study Completion Date : September 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


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

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


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00592293


Locations
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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
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Principal Investigator: Torunn Yock, MD Massachusetts General Hospital
More Information
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Responsible Party: Torunn Yock, MD, Director, Pediatric Radiation Oncology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00592293    
Other Study ID Numbers: 05-326
Other ( Other Grant/Funding Number: program income on C06 CA059267 )
First Posted: January 14, 2008    Key Record Dates
Last Update Posted: January 9, 2023
Last Verified: January 2023
Keywords provided by Torunn Yock, MD, Massachusetts General Hospital:
proton beam radiation
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms