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Proton RT for the Treatment of Pediatric Rhabdomyosarcoma

Primary Purpose

Rhabdomyosarcoma

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Proton Beam Radiation

About this trial

This is an interventional treatment trial for Rhabdomyosarcoma focused on measuring pediatric rhabdomyosarcoma, proton radiation therapy

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with biopsy proven newly diagnosed rhabdomyosarcoma.
Patients less than or equal to 21 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.

Sites / Locations

Massachusetts General HospitalRecruiting
Dana-Farber Cancer InstituteRecruiting
University of Texas MD Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Proton Beam Radiation

Arm Description

Proton Beam Radiation

Outcomes

Primary Outcome Measures

Late toxicity

Frequency and severity of late complications from irradiation using proton beam therapy in place of conventional photon beam therapy in pediatric patients with pediatric rhabdomyosarcomas.

Secondary Outcome Measures

Acute toxicity

Frequency and severity of acute side effects from irradiation using proton beam therapy in this patient population.

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.

Local Control

Rates of local control using proton radiotherapy.

Full Information

NCT ID

NCT00592592

First Posted

December 28, 2007

Last Updated

January 5, 2023

Sponsor

Massachusetts General Hospital

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00592592

Brief Title

Proton RT for the Treatment of Pediatric Rhabdomyosarcoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 2004 (Actual)

Primary Completion Date

August 2025 (Anticipated)

Study Completion Date

August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rhabdomyosarcoma

Keywords

pediatric rhabdomyosarcoma, proton radiation therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

110 (Anticipated)

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

Late toxicity

Description

Frequency and severity of late complications from irradiation using proton beam therapy in place of conventional photon beam therapy in pediatric patients with pediatric rhabdomyosarcomas.

Time Frame

4 years

Secondary Outcome Measure Information:

Title

Acute toxicity

Description

Frequency and severity of acute side effects from irradiation using proton beam therapy in this patient population.

Time Frame

4 years

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

4 years

Title

Local Control

Description

Rates of local control using proton radiotherapy.

Time Frame

4 years

10. Eligibility

Sex

All

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with biopsy proven newly diagnosed rhabdomyosarcoma. Patients less than or equal to 21 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Torunn Yock, MD

Phone

617-724-1836

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

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Torunn Yock, MD

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karen Marcus, MD

Facility Name

University of Texas MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anita Mahajan, MD

First Name & Middle Initial & Last Name & Degree

Anita Mahajan, MD

12. IPD Sharing Statement

Links:

URL

http://www.ncbi.nlm.nih.gov/pubmed/25332253

Description

Preliminary results of a phase II trial of proton radiotherapy for pediatric rhabdomyosarcoma

Learn more about this trial

Proton RT for the Treatment of Pediatric Rhabdomyosarcoma

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