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Completed

NCT Number: NCT00592293

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.

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Key information

Age range

Up to 30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Biopsy proven Non-Rhabdomyosarcoma Soft Tissue Sarcoma (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

Treatment and study plan

Proton beam radiation

Radiation

Once per day, 5 days a week for a total of 4 to 6 weeks.

Primary outcomes

  1. Cumulative Incidence (Estimated Percentage of Participants) Who Developed Toxicities Following Radiation Treatment

    Time frame: 5 years from the completion of radiation treatment

    Cumulative incidence (percent of participants and 95% confidence intervals) who experienced a grade 3, 4, or 5 late toxicity. Late complications are defined as the delayed effects attributable to radiation which occur > 90 days following completion of radiation.

  2. Local Control

    Time frame: 5 years from the start of radiation treatment

    Rates of local control using proton radiotherapy. Local control is the lack of tumor recurrence in and or near the area where the primary tumor occurred.

Secondary outcomes

  1. Dosimetric Comparison

    Time frame: 5 years

    Comparison of Dose distribution to tumor and surrounding normal structures using Dose-Volume Histograms (DVH) generated from the proton plan used to treat the patient and the photon plan generated for comparison purposes.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Boston Children's Hospital
  • Brigham and Women's Hospital
  • Dana-Farber Cancer Institute
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2006
Primary completion
2016
Study completion
2016
First posted
Jan 14, 2008
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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