Kidney NeoplasmPhase 3SABLORNCT06467097
Systemic Treatment Alone Versus Systemic Treatment Plus Radiotherapy in Oligometastatic Renal Cell Carcinoma
A Phase 3 study testing SBRT(Stereotatic Body Radiation Therapy) in people with Kidney Neoplasm, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
To evaluate whether incorporating locoregional radiotherapy in the treatment of oligometastatic renal cell carcinoma, including inductive oligometastases, along with standard systemic therapy, contributes to improved progression-free survival rates for patients. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Kidney Neoplasm
- What is being tested?
- SBRT(Stereotatic Body Radiation Therapy)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Apr 2024to 13 Feb 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with metastatic renal cell carcinoma classified within the ESTRO/EORTC classification system as having ≤ 5 metastases, ≤ 3 metastatic organs, and meeting criteria for new, recurrent, or induced metastases.
- Patients aged 20 to 80 years.
- Patients with individual metastases ≤ 5 cm in longest diameter.
- Patients with primary tumors surgically removed or scheduled for surgery.
- Patients histologically diagnosed with clear cell carcinoma.
- Patients with ECOG performance status 0-1.
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- Patients with normal major organ function and bone marrow function meeting specific criteria: WBC ≥ 2,000/μL, neutrophils ≥ 1,000/μL, platelets ≥ 50,000/μL.
- Patients who understand the contents of the informed consent form, voluntarily consent to participate in the study, and sign the informed consent form.
- Patients who agree to use contraception from the time of signing the consent form until 1 year after the last standard systemic therapy.
- Breastfeeding women who agree to stop breastfeeding for at least 5 months after the last standard systemic therapy.
- Patients with visible tumors outside the scope of tumor removal surgery (surgical therapy) for metastatic lesions.
Who cannot join
- Patients with total bilirubin > 3.6 mg/dL.
- Patients with AST >160 U/L, ALT > 165 U/L.
- Patients unable to maintain position for partial nephrectomy radiotherapy.
- Patients with a history of radiotherapy to metastatic renal cell carcinoma or surrounding areas.
- Patients with confirmed brain, peritoneal, or pleural metastases.
- Patients diagnosed with another solid tumor and treated within 2 years or with residual lesions.
- Patients who do not consent to participate in the study.
- Pregnant patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Won Park, M.D., Ph.D., +82-2-3410-2616, wonro.park@samsung.com
About this study
Official title: A Phase Ⅲ Randomized Study Systemic Treatment Alone Versus Systemic Treatment Plus Stereotactic Abative Body Radiotherapy for Patients With Oligometastatic Renal Cell Carcinoma: SABLOR Study
To evaluate whether incorporating locoregional radiotherapy in the treatment of oligometastatic renal cell carcinoma, including inductive oligometastases, along with standard systemic therapy, contributes to improved progression-free survival rates for patients.
Read the detailed description
Various institutions are attempting to use locoregional radiotherapy in the treatment of oligometastatic renal cell carcinoma, accompanied by a few metastases. Research findings have indicated that high-dose locoregional radiotherapy can suppress disease progression, potentially prolonging the interval for additional systemic therapy; however, whether the addition of locoregional radiotherapy in cases of renal cell carcinoma with oligometastases demonstrates superior oncologic outcome compared to standard systemic therapy alone has yet to be established. Therefore, a randomized phase III study is being conducted to evaluate whether incorporating locoregional radiotherapy in the treatment of oligometastatic renal cell carcinoma, including inductive oligometastases, along with standard systemic therapy, contributes to improved progression-free survival rates for patients.
- Conditions
- Kidney Neoplasm
- Being tested
- SBRT(Stereotatic Body Radiation Therapy)
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRT(Stereotatic Body Radiation Therapy)Radiation
Patients will receive treatment for one to two weeks, one to five times per region.
| Study group | Role | What they receive |
|---|---|---|
| A group | No intervention | Only standard treatment is administered. The standard treatment includes targeted cancer therapy, immunotherapy, or monotherapy with each therapeutic agent. |
| B group | Experimental | This group receives concurrent partial nephrectomy radiotherapy for all metastatic lesions in addition to standard treatment. Receives: Radiation: SBRT(Stereotatic Body Radiation Therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year progression-free survival rate
Compare free survival between the standard systemic therapy alone group and systemic therapy combined with radiotherapy group
Measured: One year after completion of enrollment
Secondary outcomes (4)
Local control rate for radiation therapy site at one year
Compare Local control rate between the standard systemic therapy alone group and systemic therapy combined with radiotherapy group
Measured: One year after radiation completion of each participant
Grade 3 acute adverse event
Compare acute adverse events according to CTCAE V5.0 between the standard systemic therapy alone group and systemic therapy combined with radiotherapy group
Measured: three to six months after study treatment
Grade 3 chronic adverse event
Compare chronic adverse events according to CTCAE V5.0 between the standard systemic therapy alone group and systemic therapy combined with radiotherapy group
Measured: one year to three years after radiation completion
Overall survival rate
Compare Overall survival rate between the standard systemic therapy alone group and systemic therapy combined with radiotherapy group
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start16 Apr 2024
- Primary completion13 Feb 2031 (estimated)
- Study completion13 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney NeoplasmStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. Control group: A group that undergoes standard treatment alone for metastatic renal cell carcinoma. 2. Experimental group: A group that receives concurrent radiotherapy for all metastatic lesions in addition to standard treatment. We will compare the one-year progression-free survival rate between these groups, randomized from a random allocation point. Block randomization will be used, with 44 participants randomly assigned to each group using a random number table generated from a web-based program.
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467097
- Sponsor's protocol ID
- SMC 2023-04-044
- Acronym
- SABLOR
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅲ Randomized Study Systemic Treatment Alone Versus Systemic Treatment Plus Stereotactic Abative Body Radiotherapy for Patients With Oligometastatic Renal Cell Carcinoma: SABLOR Study
- ClinicalTrials.gov ID
- NCT06467097
- Acronym / sponsor ID
- SABLOR / SMC 2023-04-044
- Conditions
- Kidney Neoplasm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 13 Feb 2031 (estimated)
- Study completion
- 13 Feb 2031 (estimated)
- First posted
- 20 Jun 2024 (actual)
- 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.
To evaluate whether incorporating locoregional radiotherapy in the treatment of oligometastatic renal cell carcinoma, including inductive oligometastases, along with standard systemic therapy, contributes to improved progression-free survival rates for patients.
Detailed description
Various institutions are attempting to use locoregional radiotherapy in the treatment of oligometastatic renal cell carcinoma, accompanied by a few metastases. Research findings have indicated that high-dose locoregional radiotherapy can suppress disease progression, potentially prolonging the interval for additional systemic therapy; however, whether the addition of locoregional radiotherapy in cases of renal cell carcinoma with oligometastases demonstrates superior oncologic outcome compared to standard systemic therapy alone has yet to be established. Therefore, a randomized phase III study is being conducted to evaluate whether incorporating locoregional radiotherapy in the treatment of oligometastatic renal cell carcinoma, including inductive oligometastases, along with standard systemic therapy, contributes to improved progression-free survival rates for patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1. Control group: A group that undergoes standard treatment alone for metastatic renal cell carcinoma. 2. Experimental group: A group that receives concurrent radiotherapy for all metastatic lesions in addition to standard treatment. We will compare the one-year progression-free survival rate between these groups, randomized from a random allocation point. Block randomization will be used, with 44 participants randomly assigned to each group using a random number table generated from a web-based program.
| Arm | Type | Receives |
|---|---|---|
| A group | No intervention | –Only standard treatment is administered. The standard treatment includes targeted cancer therapy, immunotherapy, or monotherapy with each therapeutic agent. |
| B group | Experimental | Radiation: SBRT(Stereotatic Body Radiation Therapy)This group receives concurrent partial nephrectomy radiotherapy for all metastatic lesions in addition to standard treatment. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with metastatic renal cell carcinoma classified within the ESTRO/EORTC classification system as having ≤ 5 metastases, ≤ 3 metastatic organs, and meeting criteria for new, recurrent, or induced metastases.
- Patients aged 20 to 80 years.
- Patients with individual metastases ≤ 5 cm in longest diameter.
- Patients with primary tumors surgically removed or scheduled for surgery.
- Patients histologically diagnosed with clear cell carcinoma.
Key exclusion criteria (8 listed)
- Patients with total bilirubin > 3.6 mg/dL.
- Patients with AST >160 U/L, ALT > 165 U/L.
- Patients unable to maintain position for partial nephrectomy radiotherapy.
- Patients with a history of radiotherapy to metastatic renal cell carcinoma or surrounding areas.
- Patients with confirmed brain, peritoneal, or pleural metastases.
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 |
|---|---|---|
| SBRT(Stereotatic Body Radiation Therapy)Patients will receive treatment for one to two weeks, one to five times per region. | Radiation | B group |
Primary outcome
1-year progression-free survival rate
Time frame: One year after completion of enrollment
Compare free survival between the standard systemic therapy alone group and systemic therapy combined with radiotherapy group
4 secondary outcomes
Local control rate for radiation therapy site at one year
Time frame: One year after radiation completion of each participant
Grade 3 acute adverse event
Time frame: three to six months after study treatment
Grade 3 chronic adverse event
Time frame: one year to three years after radiation completion
Overall survival rate
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SBRT(Stereotatic Body Radiation Therapy) in people with Kidney Neoplasm, run by Samsung Medical Center at 1 site in South Korea.
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 11 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 20 Jun 2024. 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 South Korea. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Won Park, M.D., Ph.D. (+82-2-3410-2616, wonro.park@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year progression-free survival rate (time frame: One year after completion of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jun 2024.