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

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02581384
• Other study ID #: 15-278
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: January 2017
• Est. completion date: August 2020

Study information

• Verified date: April 2021
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Clear Cell Renal Cell Carcinoma
• Ewing Sarcoma
• Neoplasm Metastasis
• Neoplasms
• Neuroectodermal Tumors, Primitive, Peripheral
• Non-Rhabdomyosarcoma Soft Tissue Sarcoma, Nos
• Osteosarcoma
• Renal Tumor
• Rhabdoid Tumor
• Rhabdomyosarcoma
• Sarcoma
• Sarcoma, Ewing
• Soft Tissue Sarcoma
• Wilms Tumor

Intervention

Radiation:
• Stereotactic Body Radiotherapy (SBRT)

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.2020.0 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Dose Limiting Toxicity [Phase I]	Dose Limiting Toxicities (DLT's) are toxicities experienced from start of therapy to 6 month. DLT's are assessed on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.; DLTs are defined as follows: Grade 2 or higher toxicities: Myelitis; Esophageal fistula, perforation, hemorrhage; Grade 3 or higher toxicities considered to be a direct result of therapy: Pneumonitis; Pericarditis, pericardial effusion; Esophageal necrosis, stenosis, ulcer; Dyspnea; Grade 4 toxicities: Esophagitis; Pericardial tamponade; Pulmonary toxicity excluding infectious pneumonia; Skin toxicity; Hemoptysis/pulmonary hemorrhage; Grade 5 toxicities, including: Pulmonary toxicity including pneumonitis; Excluding infectious pneumonia; Three participants will enter the study in each cohort. If 0/3 patients experiences a DLT, this dose level will move forward to the Phase II and more participants will be enrolled.	Up to 6 months
Primary	Overall Response Rate [Phase II]	Percentage of participants with response after 6 weeks. Response on treatment was considered to be Complete Response (CR) and Partial Response (PR) measured according Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. For target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter.	6 weeks
Secondary	Complete Response Rate [Phase II]	Percentage of pulmonary lesions of participants with response after 6 weeks. Response on treatment was considered to be Complete Response (CR) measured according Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. For target lesions, CR is complete disappearance of all target lesions.	6 weeks
Secondary	2 Year Local Control Rate [Phase II]	Rate of local control (LC) of the index lesion after lung SBRT at 2 years. LC is defined as the absence of tumor progression within 1 cm of the primary tumor site. LC is measured by established methods.	24 Months
Secondary	Percentage of Participants With 2-Year Failure-Free Survival [Phase II]	Rate of distant lung failure-free survival defined lung failure or death from any cause at two years. Lung failure defined using established methods.	24 months
Secondary	Number of Participants With Grade 3 or Higher Adverse Events [Phase I and II]	Grade 3 or higher adverse events as defined by controlled terminology criteria for adverse events (CTCAE) version 4.	Up to 6 months post-treatment (6 months and 2 weeks)