Safety and Preliminary Efficacy of SBRT in Patients With Metastatic RCC Treated With Targeted or IO Therapy

Kidney Cancer Research Bureau

Status: Completed

Conditions: Metastatic Renal Cell Carcinoma

Treatments: Radiation: SBRT

Study type: Interventional

Funder types: Other

Identifiers

NCT02864615

KCRB29022016

Details and patient eligibility

About

Aim of this phase 1b study is to evaluate safety and preliminary efficacy of stereotactic body radiation therapy in patients with metastatic renal cell carcinoma treated with VEGFR, mTOR or immune checkpoint inhibitors.

Full description

This is prospective phase 1b study.

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. clear cell renal cell carcinoma
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

1. unability to select first and second metastases
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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Stereotactic Body Radiation Therapy

Experimental group

Description:

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.

Treatment:

Radiation: SBRT