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

Primary Purpose

Non-rhabdomyosarcoma Soft Tissue Sarcoma, Bone Sarcoma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proton Beam Radiation
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-rhabdomyosarcoma Soft Tissue Sarcoma focused on measuring proton beam radiation

Eligibility Criteria

undefined - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital
  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Proton Beam Radiation

Arm Description

Proton Beam Radiation

Outcomes

Primary Outcome Measures

Acute and late toxicities
Assess frequency and severity of morbidities from irradiation using proton beam therapy in this patient population.
Local Control
Rates of local control using proton radiotherapy.

Secondary Outcome Measures

Dosimetric Comparison
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.

Full Information

First Posted
December 28, 2007
Last Updated
January 5, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Brigham and Women's Hospital, Boston Children's Hospital, Dana-Farber Cancer Institute, National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00592293
Brief Title
Proton Radiation for the Treatment of Pediatric Bone and Non-Rhabdomyosarcoma Soft Tissue Sarcomas
Official Title
Proton Radiation for the Treatment of Pediatric Bone and Non-Rhabdomyosarcoma Soft Tissue Sarcomas
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2006 (Actual)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Brigham and Women's Hospital, Boston Children's Hospital, Dana-Farber Cancer Institute, National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-rhabdomyosarcoma Soft Tissue Sarcoma, Bone Sarcoma
Keywords
proton beam radiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Proton Beam Radiation
Arm Type
Experimental
Arm Description
Proton Beam Radiation
Intervention Type
Radiation
Intervention Name(s)
Proton Beam Radiation
Intervention Description
Once per day, 5 days a week for a total of 4 to 6 weeks.
Primary Outcome Measure Information:
Title
Acute and late toxicities
Description
Assess frequency and severity of morbidities from irradiation using proton beam therapy in this patient population.
Time Frame
5 years
Title
Local Control
Description
Rates of local control using proton radiotherapy.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Dosimetric Comparison
Description
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.
Time Frame
5 years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torunn Yock, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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