Clinical trial NCT02864615: Safety and Preliminary Efficacy of SBRT in Patients With Metastatic RCC Treated With Targeted or IO Therapy
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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Renal Cell Carcinoma
Keywords: renal cell carcinoma
metastasis
stereotactic body radiation therapy
targted therapy
immune checkpoint inhibitors
Lead sponsor: Kidney Cancer Research Bureau
Sponsor class: OTHER
First posted: 2016-08-12
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of adverse events of SBRT
timeFrame: 4 months
Secondary outcomes:
measure: Rate of reduction in size of first metastasis exposed to radiation
timeFrame: 4 months
measure: Time to progression of first (study) and second (control) metastases
timeFrame: 8 months
Other outcomes:
Locations:
city: Ulyanovsk
country: Russian Federation
facility: Ulyanovsk regional cancer center
state: Ulyanovsk Region
Study officials:
affiliation: Kidney Cancer Research Bureau
name: Ilya Tsimafeyeu, M.D.
role: STUDY_DIRECTOR
affiliation: Ulyanovsk Regional Cancer Center
name: Natalia Dengina, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.