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Completed

NCT Number: NCT00592592

Proton Radiation Therapy (RT) for the Treatment of Pediatric Rhabdomyosarcoma

The main purpose of this study is to see if using proton beam radiation therapy instead of photon beam radiation therapy can reduce side effects from radiation treatment for rhabdomyosarcoma. Photon beam radiation is the standard type of radiation for treating most rhabdomyosarcoma and many other types of cancer. Photon beam radiation enters the body and passes through healthy tissue, encounters the tumor, then leaves the body through healthy tissue. A beam of proton radiation enters the body and passes through healthy tissue, encounters tumor, but then stops. This means that less healthy tissue is affected by proton beam radiation than by photon beam radiation.

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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

  • A special device is made for each participant to help them hold still during the treatment. This may be in the form of a mask or a custom made foam cradle depending on the area to be treated.
  • Radiation treatments will be given once per day, 5 days a week for a total of 4 to 6 weeks, depending upon how much total dose the tumor requires.
  • Participants will be seen once per week by their radiation doctor to monitor health and record any side effects from treatment.
  • After the radiation treatments are completed, participants will be required to undergo further tests and evaluations for several years following treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with biopsy proven newly diagnosed rhabdomyosarcoma.
  • Patients less than or equal to 30 years of age.
  • Patients must be treated with a standardly accepted chemotherapy regimen.
  • May not have metastatic disease unless aged 2-10 with embryonal histology.
  • 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, they must be willing to have their outside medical information released to us to track the results.
  • Timing of radiation must be according to the IRB protocol upon which the patient is treated within either 35 days of last chemotherapy or surgery.

Exclusion criteria

  • Life expectancy of less than 2 years.
  • Co-morbidities that would make the use of radiation too toxic to deliver safely, such as serious local injury or collagen vascular disease.
  • Patients who are pregnant
  • Previous treatment with radiation therapy.

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 Percent of Participants) With Grade 3 or Higher Toxicity in Follow-up

    Time frame: 5 years from the start of radiation treatment

    Cumulative incidence of participants who experienced a toxicity defined as either grade 3, 4, or 5 after the completion of radiation therapy in pediatric patients with pediatric rhabdomyosarcomas. Late toxicity is scored on a yearly follow-up basis for at least five years. Late toxicities will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. Cumulative incidence is shown at 5 years follow-up.

Secondary outcomes

  1. Percentage of Participants Who Experienced an Acute Toxicity by Grade

    Time frame: 3 months from radiation treatment

    Percentage of participants who experienced an acute toxicity following completion of radiation treatment by grade. Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. The recommended evaluation time for acute toxicity after radiotherapy was 6 weeks following completion, but may be at any time during the 3 months after treatment. Acute toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. Toxicities are graded on a scale of 1 to 5. A higher grade indicates a worse outcome with 1 being mild, 4 being life-threatening, and 5 being death.

  2. Dosimetric Comparison

    Time frame: 4 years from the start of radiation treatment

    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. Percent of normal tissue spared was calculated using the following equation: (100 x (mean x-ray dose - mean proton dose))/mean X-ray dose. No measure of dispersion was calculated for these estimates. The data is no longer available.

  3. Local Control

    Time frame: 5 years from the start of radiation therapy

    Estimated survival probability (defined as being free of a local recurrence) was calculated using Grays formula for competing risks

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Boston Children's Hospital
  • Brigham and Women's Hospital
  • Dana-Farber Cancer Institute
  • M.D. Anderson Cancer Center
  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

A Phase II Trial of Proton RT for the Treatment of Pediatric Rhabdomyosarcoma

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Jan 14, 2008
Registry last updated
Jun 18, 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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