Metastatic Renal Cell CarcinomaNCT02864615
Safety and Preliminary Efficacy of SBRT in Patients With Metastatic RCC Treated With Targeted or IO Therapy
A study testing SBRT in people with Metastatic Renal Cell Carcinoma, run by Kidney Cancer Research Bureau at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- What is being tested?
- SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteRussia
- Study dates
- Aug 2016to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clear cell renal cell carcinoma
- confirmed distant metastases
- previous nephrectomy
- stable disease or durable partial response on recommended targeted and IO therapy
- age: > 18 years
- signed informed consent
Who cannot join
- unability to select first and second metastases
- 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)
- other malignancy
- grade 3 and 4 toxicity of targeted therapy
Trial locations and contacts
1 site in 1 country.
About this study
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).
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.
Read the 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.
- Conditions
- Metastatic Renal Cell Carcinoma
- Being tested
- SBRT
- Keywords
- renal cell carcinoma, metastasis, stereotactic body radiation therapy, targted therapy, immune checkpoint inhibitors
- Medical subject headings
- Carcinoma, Renal Cell, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
Dose and schedule will be depended on metastases location.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Body Radiation Therapy | Experimental | 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. Receives: Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adverse events of SBRT
Measured: 4 months
Secondary outcomes (2)
Rate of reduction in size of first metastasis exposed to radiation
Measured: 4 months
Time to progression of first (study) and second (control) metastases
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionJan 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kidney Cancer Research Bureau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ilya Tsimafeyeu, M.D., Study director, Kidney Cancer Research BureauNatalia Dengina, M.D., Principal investigator, Ulyanovsk Regional Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864615
- Sponsor's protocol ID
- KCRB29022016
- Status last verified
- Oct 2019
- First submitted
- 9 Aug 2016
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31673426
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT02864615
- Acronym / sponsor ID
- KCRB29022016
- Conditions
- Metastatic Renal Cell Carcinoma
- Keywords
- renal cell carcinoma, metastasis, stereotactic body radiation therapy, targted therapy, immune checkpoint inhibitors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Kidney Cancer Research BureauUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Body Radiation Therapy | Experimental | Radiation: SBRTPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- clear cell renal cell carcinoma
- confirmed distant metastases
- previous nephrectomy
- stable disease or durable partial response on recommended targeted and IO therapy
- age: > 18 years
Key exclusion criteria (4 listed)
- unability to select first and second metastases
- 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)
- other malignancy
- grade 3 and 4 toxicity of targeted therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBRTDose and schedule will be depended on metastases location. | Radiation | Stereotactic Body Radiation Therapy |
Primary outcome
Rate of adverse events of SBRT
Time frame: 4 months
2 secondary outcomes
Rate of reduction in size of first metastasis exposed to radiation
Time frame: 4 months
Time to progression of first (study) and second (control) metastases
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- Derived from this study: PubMed 31673426Dengina 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilya Tsimafeyeu, M.D. study director
Kidney Cancer Research Bureau
Natalia Dengina, M.D. principal investigator
Ulyanovsk Regional Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBRT in people with Metastatic Renal Cell Carcinoma, run by Kidney Cancer Research Bureau at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of adverse events of SBRT (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02864615, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2019.