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

Dana-Farber Cancer Institute

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Osteosarcoma; Non-Rhabdomyosarcoma Soft Tissue Sarcoma, Nos; Sarcoma; Rhabdomyosarcoma; Soft Tissue Sarcoma; Wilms Tumor; Rhabdoid Tumor; Ewing Sarcoma; Clear Cell Renal Cell Carcinoma; Sarcoma, Ewing; Renal Tumor

Treatments: Radiation: Stereotactic Body Radiotherapy (SBRT)

Study type: Interventional

Funder types: Other

Identifiers

NCT02581384

15-278

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 6 patient groups

Cohort 1 Dose Level 1 [Phase I]

Experimental group

Description:

Participants with Wilms tumors or other primary renal tumors. Stereotactic Body Radiotherapy (SBRT) Dose Levels for each target lesion are three 8 Gy fractions for 24 Gy total.

Treatment:

Radiation: Stereotactic Body Radiotherapy (SBRT)

Cohort 1 Dose Level 2 [Phase I]

Experimental group

Description:

Participants with Wilms tumors or other primary renal tumors. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total.

Treatment:

Radiation: Stereotactic Body Radiotherapy (SBRT)

Cohort 1 Dose Level 3 [Phase I]

Experimental group

Description:

Participants with Wilms tumors or other primary renal tumors. SBRT Dose Levels for each target lesion are three 12 Gy fractions for 36 Gy total.

Treatment:

Radiation: Stereotactic Body Radiotherapy (SBRT)

Cohort 2 Dose Level 2 [Phase I]

Experimental group

Description:

Participants with Ewing sarcoma or rhabdomyosarcoma. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total.

Treatment:

Radiation: Stereotactic Body Radiotherapy (SBRT)

Cohort 2 Dose Level 3 [Phase I]

Experimental group

Description:

Participants with Ewing sarcoma or rhabdomyosarcoma.SBRT Dose Levels for each target lesion are three 12 Gy fractions for 36 Gy total.

Treatment:

Radiation: Stereotactic Body Radiotherapy (SBRT)

Cohort 2 Dose Level 2 [Phase II]

Experimental group

Description:

Participants with Ewing sarcoma or rhabdomyosarcoma. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total.

Treatment:

Radiation: Stereotactic Body Radiotherapy (SBRT)