Safety and Preliminary Efficacy of SBRT in Patients With Metastatic RCC Treated With Targeted or IO Therapy
NCT ID: NCT02864615
Last Updated: 2019-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
17 participants
INTERVENTIONAL
2016-08-31
2018-08-31
Brief Summary
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Detailed Description
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Patients with metastatic RCC receiving targeted or IO therapy (VEGFR inhibitor or mTOR inhibitor or checkpoint inhibitors in approved treatment lines and in standard therapeutic regimens) with stable diseaseor durable partial response for at least 4 months, are enrolled in the study.
The initial examination includes CT with contrast, where the selected measured 2 metastatic sites, stable for at least 4 months but no more than 6 months of targeted therapy (increase or decrease in size in the course of targeted therapy should not exceed 10%). Metastases have to be located in one organ. Allowed location of metastases: lungs, liver, lymph nodes, contralateral kidney, adrenal gland.
Size of selected metastases should not be less than 5 mm and not more than 4 cm.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Stereotactic Body Radiation Therapy
Patients with stable disease on targeted or IO therapy will receive SBRT on first metastasis of clear cell renal cell carcinoma. Second metastasis will be as a control. In case of safety and 50% reduction in size of first metastasis, up to 10 metastasis will be treated with SBRT.
SBRT
Dose and schedule will be depended on metastases location.
Interventions
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SBRT
Dose and schedule will be depended on metastases location.
Eligibility Criteria
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Inclusion Criteria
2. confirmed distant metastases
3. previous nephrectomy
4. stable disease or durable partial response on recommended targeted and IO therapy
5. age: \> 18 years
6. signed informed consent
Exclusion Criteria
2. history of serious cardiac arrhythmia, congestive heart failure, angina pectoris, or other severe cardiovascular disease (i.e., New York Heart Association class III or IV)
3. other malignancy
4. grade 3 and 4 toxicity of targeted therapy
18 Years
75 Years
ALL
No
Sponsors
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Kidney Cancer Research Bureau
OTHER
Responsible Party
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Principal Investigators
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Ilya Tsimafeyeu, M.D.
Role: STUDY_DIRECTOR
Kidney Cancer Research Bureau
Natalia Dengina, M.D.
Role: PRINCIPAL_INVESTIGATOR
Ulyanovsk Regional Cancer Center
Locations
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Ulyanovsk regional cancer center
Ulyanovsk, Ulyanovsk Oblast, Russia
Countries
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References
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Dengina N, Mitin T, Gamayunov S, Safina S, Kreinina Y, Tsimafeyeu I. Stereotactic body radiation therapy in combination with systemic therapy for metastatic renal cell carcinoma: a prospective multicentre study. ESMO Open. 2019 Oct 13;4(5):e000535. doi: 10.1136/esmoopen-2019-000535. eCollection 2019.
Other Identifiers
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KCRB29022016
Identifier Type: -
Identifier Source: org_study_id
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