Stereotactic Body Radiotherapy in Treating Lung Metastases in Patients with Ewing Sarcoma, Rhabdomyosarcoma, or Wilms Tumors
- Diagnosis of Ewing sarcoma, rhabdomyosarcoma, osteosarcoma, non-rhabdomyosarcoma soft tissue sarcoma, Wilms tumor or other primary renal tumor (including clear cell and rhabdoid)
- Must be capable of treatment without general anesthesia
- Lesion size 4 mm - 3 cm
- Subjects who have lesions within 2 cm of central structures, will be eligible on a case-by-case basis * Tumor within or touching the zone of the proximal bronchial tree, defined as a volume 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)
- 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 forced expiratory volume in 1 second (FEV1) >= 50% of predicted
- Concurrent immunotherapy is allowed
- Prior whole-lung or hemi-thorax irradiation of greater than 12 gray (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
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)
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.
Trial Phase Phase I/II
Trial Type Treatment
Dana-Farber Harvard Cancer Center
Karen Jean Chayt Marcus
- Primary ID 15-278
- Secondary IDs NCI-2016-00890
- Clinicaltrials.gov ID NCT02581384