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

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2020-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

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Stereotactic Body Radiotherapy (SBRT)

Intervention Type RADIATION

Eligibility Criteria

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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

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No