This phase I/II trial studies the side effects and best dose of stereotactic body radiotherapy and to see how well it works in treating cancer that has spread to the lung in patients with Ewing sarcoma, rhabdomyosarcoma, or Wilms tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02581384.
PRIMARY OBJECTIVES:
I. To determine the tolerability and safety of stereotactic body radiotherapy for pulmonary metastases in pediatric patients with Ewing sarcoma, rhabdomyosarcoma or Wilms tumor and other primary renal tumors. (Phase I)
II. To evaluate disease response at 6 weeks post stereotactic body radiotherapy (SBRT) in this patient population. (Phase II)
SECONDARY OBJECTIVES:
I. To determine the feasibility of SBRT in the pediatric population (including tolerability).
II. To document the safety of the treatment.
III. To determine rate of relapse elsewhere in the lung.
IV. Best overall response.
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Patients undergo 3 fractions of SBRT over 1-2 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1 month, 6-8 weeks, and every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorKaren Jean Chayt Marcus
