Summary
This research study is studying stereotactic body radiotherapy (SBRT) as a possible treatment for lung relapse of Ewing sarcoma, rhabdomyosarcoma, osteosarcoma, non-rhabdomyosarcoma soft tissue sarcoma, Wilms tumor or other primary renal tumor (including clear cell and rhabdoid). SBRT is a form of targeted radiotherapy that can treat very small tumors using a few large doses.
Conditions
Ewing Sarcoma, Rhabdomyosarcoma, Wilms Tumor, Osteosarcoma, Non-Rhabdomyosarcoma Soft Tissue Sarcoma, Nos, Renal Tumor, Rhabdoid Tumor, Clear Cell Renal Cell Carcinoma, Sarcoma, Sarcoma, Ewing, Soft Tissue Sarcoma
Recruitment Status
Terminated
Detailed Description
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.
Eligibility Criteria
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
Intervention
Intervention Type
Intervention Name
Radiation
Stereotactic Body Radiotherapy (SBRT)
Phase
Phase 1, Phase 2
Gender
All
Min Age
N/A
Max Age
21 Years
Download Date
April 30, 2021
Principal Investigator
Karen J Marcus, MD FACR
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: