Clinical Trial: Stereotactic Body Radiotherapy (SBRT) for Pulmonary Metastases in Ewing Sarcoma, Rhabdomyosarcoma, and Wilms Tumors

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Stereotactic Body Radiotherapy (SBRT) for Pulmonary Metastases in Ewing Sarcoma, Rhabdomyosarcoma, and Wilms Tumors

Brief Summary: This research study is studying stereotactic body radiotherapy (SBRT) as a possible treatment for lung relapse of Ewing Sarcoma, Rhabdomyosarcoma, or Wilms Tumor. SBRT is a form of targeted radiotherapy that can treat very small tumors using a few large doses.

Detailed Summary: This research study is a Pilot Study, also known as a Phase I-II study, which means it is the first time investigators are examining this study intervention for patients with lung recurrence of Ewing Sarcoma, Rhabdomyosarcoma, or Wilms Tumor. This study tests the most appropriate dose, safety and efficacy of SBRT for the treatment of lung recurrence of Wilms tumor, rhabdomyosarcoma, or Ewing sarcoma in children. Standard radiotherapy is typically used to treat Ewing sarcoma and is used to treat lung recurrence. SBRT is being used to treat adults with small inoperable lung cancers; in such cases, SBRT has been shown to be effective and well-tolerated. SBRT is also used to treat bone metastases in adults and children.
Sponsor: Dana-Farber Cancer Institute

Current Primary Outcome:

  • Dose Limiting Toxicity [ Time Frame: 6 Months ]
    The Phase I portion will evaluate the toxicity profile of each dose level and determine whether a given dose level could move forward to the Phase II portion
  • Overall Response [ Time Frame: 6 weeks ]
    Response after 6 weeks will be assessed


Original Primary Outcome: Same as current

Current Secondary Outcome: Best Overall Response [ Time Frame: 2 years ]

The Kaplan and Meier method will be used to measure relapse time elsewhere in the lung. All patients who takes part in the treatment will be monitored for toxicity, and the percent of patients with various toxicities will be calculated for each dose level.


Original Secondary Outcome: Same as current

Information By: Dana-Farber Cancer Institute

Dates:
Date Received: October 19, 2015
Date Started: May 2016
Date Completion: February 2023
Last Updated: August 3, 2016
Last Verified: August 2016