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



Status:Recruiting
Conditions:Lung Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 21
Updated:3/24/2019
Start Date:May 2016
End Date:February 2029
Contact:Karen J Marcus, MD
Email:karen_marcus@dfci.harvard.edu
Phone:617-732-8783

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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.

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.

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
We found this trial at
3
sites
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Karen J Marcus, MD
Phone: 617-355-8399
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Karen J Marcus, MD
Phone: 617-355-8399
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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from
Boston, MA
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
?
mi
from
Boston, MA
Click here to add this to my saved trials