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

Not Applicable

Completed

• Conditions: Metastatic Renal Cell Carcinoma
• Interventions: Radiation: SBRT

• Registration Number: NCT02864615
• Lead Sponsor: Kidney Cancer Research Bureau

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-09
• Study First Submitted QC: 2016-08-09
• Study First Posted: 2016-08-12
• Primary Completion: 2018-01
• Study Completion: 2018-08
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-18
• Last Update Posted: 2019-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stereotactic Body Radiation Therapy	SBRT	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.

Primary Outcome Measures

Name	Time	Method
Rate of adverse events of SBRT	4 months

Secondary Outcome Measures

Name	Time	Method
Rate of reduction in size of first metastasis exposed to radiation	4 months
Time to progression of first (study) and second (control) metastases	8 months

Trial Locations

Locations (1)

Ulyanovsk regional cancer center; 🇷🇺 Ulyanovsk, Ulyanovsk Region, Russian Federation