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

Metastatic Renal Cell Carcinoma Clinical Trial

Official title:

A Phase 1b Study of Safety and Preliminary Efficacy of Stereotactic Body Radiation Therapy (SBRT) in Patients With Metastatic Renal Cell Carcinoma Treated With Targeted or Immuno- Therapy (Volga Study).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02864615
• Other study ID #: KCRB29022016
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: August 2018

Study information

• Verified date: October 2019
• Source: Kidney Cancer Research Bureau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: August 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Metastatic Renal Cell Carcinoma

Intervention

Radiation:
• SBRT
Dose and schedule will be depended on metastases location.

Locations

Country	Name	City	State
Russian Federation	Ulyanovsk regional cancer center	Ulyanovsk	Ulyanovsk Region

Sponsors (1)

Lead Sponsor	Collaborator
Kidney Cancer Research Bureau

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of adverse events of SBRT		4 months
Secondary	Rate of reduction in size of first metastasis exposed to radiation		4 months
Secondary	Time to progression of first (study) and second (control) metastases		8 months