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

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, osteosarcoma, nonrhabdomyosarcoma soft tissue
sarcoma, Wilms tumor or other primary renal tumor (including clear cell and rhabdoid). This
study tests the most appropriate dose, safety and efficacy of SBRT for the treatment of lung
recurrence of these cancers 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.

Inclusion Criteria:

- Diagnosis of Ewing sarcoma, rhabdomyosarcoma, osteosarcoma, non-rhabdomyosarcoma soft
tissue sarcoma, Wilms tumor or other primary renal tumor (including clear cell and
rhabdoid)

- Age ≤ 21 years;

- Must be capable of treatment without general anesthesia

- Lesion size 8 mm - 3 cm

- Subjects who have lesions within 2 cm of central structures, will be eligible on a
case by-case basis

- Pulmonary metastases found at relapse (does not have to be first relapse); no more
than 3 lesions per hemi-thorax will be treated but other lesions in the lung may be
present

- Greater than 5 weeks from doxorubicin at the time of consent, with radiation to be
initiated no less than 6 weeks from doxorubicin

- Informed consent/assent

- Life expectancy >3 months

- Pulmonary Function FEV1 ≥ 50% of predicted;

- Concurrent immunotherapy is allowed

Exclusion Criteria:

- Prior whole-lung or hemi-thorax irradiation of greater than 12 Gy received less than 6
months prior to consent (focal radiotherapy to the thorax is not an exclusion)

- Lesion larger than 3 cm in diameter

- Patients for whom surgery would be deemed appropriate rather than radiotherapy