Stereotactic Body Radiotherapy (SBRT) for Pulmonary Metastases in Ewing Sarcoma, Rhabdomyosarcoma, and Wilms Tumors
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02581384 |
Recruitment Status :
Active, not recruiting
First Posted : October 21, 2015
Last Update Posted : January 20, 2021
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Condition or disease | Intervention/treatment | Phase |
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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 | Radiation: Stereotactic Body Radiotherapy (SBRT) | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 5 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Stereotactic Body Radiotherapy (SBRT) for Pulmonary Metastases in Ewing Sarcoma, Rhabdomyosarcoma, and Wilms Tumors |
Study Start Date : | May 2016 |
Actual Primary Completion Date : | August 2020 |
Estimated Study Completion Date : | February 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Stereotactic Body Radiotherapy
Stereotactic Body Radiotherapy (SBRT)
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Radiation: Stereotactic Body Radiotherapy (SBRT) |
- Dose Limiting Toxicity [ Time Frame: 6 Months ]The Phase I portion will evaluate the toxicity profile of each dose level and determine whether a given dose level could move forward to the Phase II portion
- Overall Response [ Time Frame: 6 weeks ]Response after 6 weeks will be assessed
- Best Overall Response [ Time Frame: 2 years ]The Kaplan and Meier method will be used to measure relapse time elsewhere in the lung. All patients who takes part in the treatment will be monitored for toxicity, and the percent of patients with various toxicities will be calculated for each dose level.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | up to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02581384
United States, Massachusetts | |
Boston Children's Hospital | |
Boston, Massachusetts, United States, 02115 | |
Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02215 |
Principal Investigator: | Karen Marcus, MD | Dana-Farber Cancer Institute |
Responsible Party: | Karen J Marcus, MD FACR, Karen J Marcus, M.D., Boston Children's Hospital |
ClinicalTrials.gov Identifier: | NCT02581384 |
Other Study ID Numbers: |
15-278 |
First Posted: | October 21, 2015 Key Record Dates |
Last Update Posted: | January 20, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Ewing Sarcoma Rhabdomyosarcoma Wilms Tumor Rhabdomyosarcoma of Mediastinum Ewing's Sarcoma Metastatic Ewing Family of Tumors Ewing's Tumor Metastatic Osteosarcoma, Metastatic Osteosarcoma in Children Rhabdoid Tumor |
Lung Metastasis Radiation for Children SBRT for children Stereotactic Body Radiotherapy Pulmonary Metastasis Lung Metastasis in Children Pulmonary Metastasis in Children Comfort Care Palliative Care |
Neoplasms Neoplasm Metastasis Sarcoma Carcinoma, Renal Cell Osteosarcoma Rhabdomyosarcoma Sarcoma, Ewing Wilms Tumor Rhabdoid Tumor Neuroectodermal Tumors, Primitive, Peripheral Neoplastic Processes Pathologic Processes Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Adenocarcinoma |
Carcinoma Neoplasms, Glandular and Epithelial Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Neoplasms, Bone Tissue Neoplasms, Connective Tissue Myosarcoma Neoplasms, Muscle Tissue Neoplasms, Complex and Mixed Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn |