Clinical trial NCT02581384: Stereotactic Body Radiotherapy (SBRT) for Pulmonary Metastases in Ewing Sarcoma, Rhabdomyosarcoma, and Wilms Tumors
Official title: Stereotactic Body Radiotherapy (SBRT) for Pulmonary Metastases in Ewing Sarcoma, Rhabdomyosarcoma, and Wilms Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
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
Keywords: 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
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2015-10-21
Enrollment: 5
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Number of Participants With Dose Limiting Toxicity [Phase I]
timeFrame: Up to 6 months
measure: Overall Response Rate [Phase II]
timeFrame: 6 weeks
Secondary outcomes:
measure: Complete Response Rate [Phase II]
timeFrame: 6 weeks
measure: 2 Year Local Control Rate [Phase II]
timeFrame: 24 Months
measure: Percentage of Participants With 2-Year Failure-Free Survival [Phase II]
timeFrame: 24 months
measure: Number of Participants With Grade 3 or Higher Adverse Events [Phase I and II]
timeFrame: Up to 6 months post-treatment (6 months and 2 weeks)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Karen Marcus, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu KX, Chen YH, Kozono D, Mak RH, Boyle PJ, Janeway KA, Mullen EA, Marcus KJ. Phase I/II Study of Stereotactic Body Radiation Therapy for Pulmonary Metastases in Pediatric Patients. Adv Radiat Oncol. 2020 Sep 23;5(6):1267-1273. doi: 10.1016/j.adro.2020.09.004. eCollection 2020 Nov-Dec.