Trial record 3 of 49 for:    Open Studies | "Rhabdomyosarcoma"

Proton RT for the Treatment of Pediatric Rhabdomyosarcoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Massachusetts General Hospital
Sponsor:
Collaborators:
M.D. Anderson Cancer Center
Brigham and Women's Hospital
Children's Hospital Boston
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Torunn Yock, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00592592
First received: December 28, 2007
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Rhabdomyosarcoma
Radiation: Proton Beam Radiation
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Proton RT for the Treatment of Pediatric Rhabdomyosarcoma

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Late toxicity [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    Frequency and severity of acute side effects from irradiation using proton beam therapy in this patient population.

  • Dosimetric comparison [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Rates of local control using proton radiotherapy.


Estimated Enrollment: 80
Study Start Date: October 2004
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592592

Contacts
Contact: Torunn Yock, MD 617-724-1836

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Torunn Yock, MD         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Karen Marcus, MD         
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Anita Mahajan, MD         
Principal Investigator: Anita Mahajan, MD         
Sponsors and Collaborators
Massachusetts General Hospital
M.D. Anderson Cancer Center
Brigham and Women's Hospital
Children's Hospital Boston
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Torunn Yock, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Torunn Yock, MD, Director, Pediatric Radiation Oncology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00592592     History of Changes
Other Study ID Numbers: 04-188, P01CA021239
Study First Received: December 28, 2007
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
pediatric rhabdomyosarcoma
proton radiation therapy

Additional relevant MeSH terms:
Rhabdomyosarcoma
Rhabdomyosarcoma, Embryonal
Myosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma

ClinicalTrials.gov processed this record on July 24, 2014