Kidney NeoplasmSABINANCT05817604
Stereotactic Body Radiotherapy (SBRT) for Medically Inoperable Localised Renal Tumors (SABINA Trial)
An observational study of Kidney Neoplasm and Renal Cancer, run by Consorci Sanitari de Terrassa at 1 site in Spain.
Trial summary
Study evaluating the activity and efficacy of Stereotactic Body Radiotherapy for the treatment of medically inoperable localized renal cancer Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Neoplasm, Renal Cancer, Inoperable Disease
- What is being tested?
- SBRT
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2023to 1 May 2028
- Phase
- Observational
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants diagnosed with localized renal cancer selected by each tumor board from Consorci Sanitari de Terrassa (CST) collaborative group medical centers
Who may be able to join
- Histological diagnosis of Renal tumor and/or highly suspected malignant neoplasm by CT, MRI or PET.
- Tumor Diameter >1cm - <7cm
- Tumor visible on CT planning
- Medically inoperable disease (or rejection of surgery)
- Karnofsky Index >70%
- >18 y.o.
- Informed Consent signature
Who cannot join
- Non-oncological renal disease or autoinmunological disorder that does not recommend the treatment with radiotherapy.
- Previous local/regional RT
- Life expectancy <6 months
- Concomitance with other antineoplastic drugs
Trial locations and contacts
1 site in 1 country.
About this study
Study evaluating the activity and efficacy of Stereotactic Body Radiotherapy for the treatment of medically inoperable localized renal cancer
Read the detailed description
Stereotactic Body Radiotherapy (SBRT) is a non-invasive alternative to surgery to control localized primary renal cell cancer (RCC) in medically inoperable patients. The kidney tumor has classically been considered radioresistant. Multiple retrospective series and few Phase II trial have studied the role of SBRT in localized renal tumors with favorable outcomes. Although large prospective studies are lacking, we evaluate the safety and effectiveness of SBRT for the treatment of renal cancer.
Participants will be allocated to recieve either single 26Gy fraction or Multifraction 3 - 5 fraction-squeme.
Assesment at regular intervals will estimate the activity and efficacy of the technique, evaluate tolerability, estimate survival, estimate distant failure rate, and renal function change after SABR.
Follow-up visits occur at 1month and every 3 months in the first year after SBRT, then every 6 months in the second year and then yearly until study closure.
- Conditions
- Kidney Neoplasm, Renal Cancer, Inoperable Disease, SBRT, SABR
- Being tested
- SBRT
- Keywords
- Stereotactic Body Radiotherapy, Renal Cancer, Primary Localized Renal Cancer, Kidney Neoplasm, Radiotherapy, Inoperable Cancer, Stereotactic ablative radiotherapy, SBRT, SABR
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
Tumors ≤ 4cm: Single SBRT 26Gy dose or Multifraction SBRT dose 14Gyx3 fraction-squeme.
Tumors ≥ 4cm: Multifraction SBRT dose 14Gyx3 or 9Gyx5 fraction-squeme.
| Study group | Role | What they receive |
|---|---|---|
| Localized Renal Cancer-One arm | Patients diagnosed with medically inoperable localized renal cancer [Size <7cm (cT1b)] based on TC, MRI or PET Image Study. Receives: Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local relapse-free survival
Local Control assessed by RECISTv1.1 criteria with TC, MRI or PET-scan
Measured: Participants should be followed continuously during 5 years
Secondary outcomes (5)
Metastases-Free Survival
Metastases-Free Survival assessed by RECISTv1.1 criteria with TC, MRI or PET-scan
Measured: Participants should be followed continuously during 5 years
Overall Survival
Defined as the time from diagnose to the date of death from any cause.
Measured: Participants should be followed continuously during 5 years
Cancer Specific Survival
Defined as the time from diagnose to the date of death from renal cancer.
Measured: Participants should be followed continuously during 5 years
Renal treatment-related adverse events
Specific Renal Function-related adverse events measured by estimate Glomerular Filtration Rate
Measured: Participants should be followed continuously during 5 years
Non-Renal treatment-related adverse events
Number of patients with Non-Renal treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v5.0
Measured: Participants should be followed continuously during 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Mar 2023
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2028 (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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de Terrassa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Galdeano-Rubio, Consorci Sanitari de Terrassa
- Investigators
- Manuel Galdeano-Rubio, MD, Principal investigator, Consorci Sanitari de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817604
- Sponsor's protocol ID
- SABINA
- Acronym
- SABINA
- Status last verified
- May 2024
- First submitted
- 5 Apr 2023
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Body Radiotherapy (SBRT) for Medically Inoperable Localised Renal Tumors (SABINA Trial)
- ClinicalTrials.gov ID
- NCT05817604
- Acronym / sponsor ID
- SABINA / SABINA
- Conditions
- Kidney Neoplasm, Renal Cancer, Inoperable Disease, SBRT, SABR
- Keywords
- Stereotactic Body Radiotherapy, Renal Cancer, Primary Localized Renal Cancer, Kidney Neoplasm, Radiotherapy, Inoperable Cancer, Stereotactic ablative radiotherapy, SBRT
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Consorci Sanitari de TerrassaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 18 Apr 2023 (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.
Study evaluating the activity and efficacy of Stereotactic Body Radiotherapy for the treatment of medically inoperable localized renal cancer
Detailed description
Stereotactic Body Radiotherapy (SBRT) is a non-invasive alternative to surgery to control localized primary renal cell cancer (RCC) in medically inoperable patients. The kidney tumor has classically been considered radioresistant. Multiple retrospective series and few Phase II trial have studied the role of SBRT in localized renal tumors with favorable outcomes. Although large prospective studies are lacking, we evaluate the safety and effectiveness of SBRT for the treatment of renal cancer.
Participants will be allocated to recieve either single 26Gy fraction or Multifraction 3 - 5 fraction-squeme.
Assesment at regular intervals will estimate the activity and efficacy of the technique, evaluate tolerability, estimate survival, estimate distant failure rate, and renal function change after SABR.
Follow-up visits occur at 1month and every 3 months in the first year after SBRT, then every 6 months in the second year and then yearly until study closure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Localized Renal Cancer-One arm | – | Radiation: SBRTPatients diagnosed with medically inoperable localized renal cancer [Size <7cm (cT1b)] based on TC, MRI or PET Image Study. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants diagnosed with localized renal cancer selected by each tumor board from Consorci Sanitari de Terrassa (CST) collaborative group medical centers
Key inclusion criteria (7 listed)
- Histological diagnosis of Renal tumor and/or highly suspected malignant neoplasm by CT, MRI or PET.
- Tumor Diameter >1cm - <7cm
- Tumor visible on CT planning
- Medically inoperable disease (or rejection of surgery)
- Karnofsky Index >70%
Key exclusion criteria (4 listed)
- Non-oncological renal disease or autoinmunological disorder that does not recommend the treatment with radiotherapy.
- Previous local/regional RT
- Life expectancy <6 months
- Concomitance with other antineoplastic drugs
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 |
|---|---|---|
| SBRTTumors ≤ 4cm: Single SBRT 26Gy dose or Multifraction SBRT dose 14Gyx3 fraction-squeme. Tumors ≥ 4cm: Multifraction SBRT dose 14Gyx3 or 9Gyx5 fraction-squeme. | Radiation | Localized Renal Cancer-One arm |
Primary outcome
Local relapse-free survival
Time frame: Participants should be followed continuously during 5 years
Local Control assessed by RECISTv1.1 criteria with TC, MRI or PET-scan
5 secondary outcomes
Metastases-Free Survival
Time frame: Participants should be followed continuously during 5 years
Overall Survival
Time frame: Participants should be followed continuously during 5 years
Cancer Specific Survival
Time frame: Participants should be followed continuously during 5 years
Renal treatment-related adverse events
Time frame: Participants should be followed continuously during 5 years
Non-Renal treatment-related adverse events
Time frame: Participants should be followed continuously during 5 years
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 10 May 2024.
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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.
Manuel Galdeano-Rubio, MD principal investigator
Consorci Sanitari de Terrassa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Neoplasm and Renal Cancer, run by Consorci Sanitari de Terrassa at 1 site in Spain.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 10 May 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 Spain. 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?
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?
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?
Local relapse-free survival (time frame: Participants should be followed continuously during 5 years). 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 10 May 2024.