Renal Cell Carcinoma (RCC)CT-STARRSNCT07402109
CBCT Guided Markerless SBRT for Renal Cell Cancer
A study testing Additional radiation due to imaging in people with Renal Cell Carcinoma (RCC), run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
This study aims to improve the treatment of kidney tumors using radiotherapy, by investigating whether kidney cancer can be more effectively irradiated with the help of new imaging techniques Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma (RCC)
- What is being tested?
- Additional radiation due to imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2026to 1 Jan 2030
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically proven non-metastastic RCC or high suspicion of RCC based on imaging without histological evidence
- No metastatic lesions
- Patients must be 18 years or older
- Ability to understand the requirements of the study and to give written informed consent, as determined by the treating physician.
- Written informed consent
Who cannot join
- Previous high-dose radiotherapy in the region of the kidney
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus MC
Rotterdam, South Holland, 3000CA
Department of radiotherapy, 010-7041013, algemeen.secr.rt@erasmusmc.nl
About this study
Official title: Organ Sparing Marker-less CBCT-guided Stereotactic Adaptive Radiotherapy for Primary Non-metastasized Renal Tumors
This study aims to improve the treatment of kidney tumors using radiotherapy, by investigating whether kidney cancer can be more effectively irradiated with the help of new imaging techniques
Read the detailed description
In total 40 patients will be treated for RCC using SBRT.
For 15 patients, additional breath-hold CBCT scans will be made during SBRT to investigate the intra- and inter-fraction uncertainty in breath-hold positions as well as assessing the feasibility of using surface guidance as a surrogate for target position.
Subsequently, 25 patients will be treated using the new motion management technique developed using the extra imaging data obtained from the first cohort of patients. It is hypothesized that either breath-hold or gating in combination with surface guidance will result in a reproducible (stable) position of the target and therefore minimal margins.
- Conditions
- Renal Cell Carcinoma (RCC)
- Being tested
- Additional radiation due to imaging
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional radiation due to imagingRadiation
Additional imaging will be done using CT, therefore the patient will receive additional radiation dose
| Study group | Role | What they receive |
|---|---|---|
| Additional imaging | Experimental | Additional CBCT scans will be made after each fraction, follow-up will be done using photon counting CT Receives: Radiation: Additional radiation due to imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of renal dose
The primary aim of this project is to minimize treatment margins, reducing the PTV, to optimally preserve renal function, while ensuring adequate tumor coverage as well as adhering to dose constraints of OARs. Primary endpoint of this study is the reduction of dose to the healthy ipsilateral kidney, defined as the ipsilateral renal volume receiving 50% of the prescribed dose (V50%).
Measured: At day 1 planning CTs are acquired for treatment planning. These scans will be used to make a treatment planning with standard motion management and a treatment planning will be made using novel motion management. Both plans will be compared.
Secondary outcomes (4)
Evaluate the current treatment, including the benefit of online adaptive radiotherapy
The possible benefit of online adaptive radiotherapy will be assessed by doing an offline analysis by comparing target coverage in % between adapted and non-adapted, original plans
Measured: Day 1 planning CTs. Approximately day 14: start radiotherapy (3 times per week). At each fraction: CBCT. At completion of treatment (at approximately day 30) planning for adapted and non-adapted plans
Investigate treatment fraction reduction
the feasibility of transitioning from a 5×8 Gy schedule to 3×14 Gy or 1×26 Gy will be investigated by simulating the difference in the mean number of fractions when using SoC motion management and the novel motion management
Measured: At day 1 planning CTs are acquired for treatment planning. These will be used for treatment planning for simulated fraction schedules using standard and novel motion management
Change From Baseline in Tumor Contrast Enhancement on Photon-Counting CT
Tumor contrast enhancement measured on contrast-enhanced photon-counting CT scans. Enhancement values will be quantified within the treated lesion and reported as change from baseline.
Measured: Baseline (pre-treatment) and follow-up at 3, 6, and 12 months after completion of treatment
Change From Baseline in Tumor Iodine Concentration on Photon-Counting CT
Iodine concentration quantified within the treated lesion using material decomposition from contrast-enhanced photon-counting CT scans. Values will be reported as change from baseline.
Measured: Baseline (pre-treatment) and follow-up at 3, 6, and 12 months after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start1 Apr 2026
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Carcinoma (RCC)Studies of the same condition, open and under way.
- More trials run by Erasmus 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, E. (Euphemia) A.M. Froklage, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402109
- Sponsor's protocol ID
- NL-010279
- Acronym
- CT-STARRS
- Status last verified
- Apr 2026
- First submitted
- 30 Sep 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organ Sparing Marker-less CBCT-guided Stereotactic Adaptive Radiotherapy for Primary Non-metastasized Renal Tumors
- ClinicalTrials.gov ID
- NCT07402109
- Acronym / sponsor ID
- CT-STARRS / NL-010279
- Conditions
- Renal Cell Carcinoma (RCC)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 11 Feb 2026 (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.
This study aims to improve the treatment of kidney tumors using radiotherapy, by investigating whether kidney cancer can be more effectively irradiated with the help of new imaging techniques
Detailed description
In total 40 patients will be treated for RCC using SBRT.
For 15 patients, additional breath-hold CBCT scans will be made during SBRT to investigate the intra- and inter-fraction uncertainty in breath-hold positions as well as assessing the feasibility of using surface guidance as a surrogate for target position.
Subsequently, 25 patients will be treated using the new motion management technique developed using the extra imaging data obtained from the first cohort of patients. It is hypothesized that either breath-hold or gating in combination with surface guidance will result in a reproducible (stable) position of the target and therefore minimal margins.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Additional imaging | Experimental | Radiation: Additional radiation due to imagingAdditional CBCT scans will be made after each fraction, follow-up will be done using photon counting CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with histologically proven non-metastastic RCC or high suspicion of RCC based on imaging without histological evidence
- No metastatic lesions
- Patients must be 18 years or older
- Ability to understand the requirements of the study and to give written informed consent, as determined by the treating physician.
- Written informed consent
Key exclusion criteria (1 listed)
- Previous high-dose radiotherapy in the region of the kidney
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 |
|---|---|---|
| Additional radiation due to imagingAdditional imaging will be done using CT, therefore the patient will receive additional radiation dose | Radiation | Additional imaging |
Primary outcome
Reduction of renal dose
Time frame: At day 1 planning CTs are acquired for treatment planning. These scans will be used to make a treatment planning with standard motion management and a treatment planning will be made using novel motion management. Both plans will be compared.
The primary aim of this project is to minimize treatment margins, reducing the PTV, to optimally preserve renal function, while ensuring adequate tumor coverage as well as adhering to dose constraints of OARs. Primary endpoint of this study is the reduction of dose to the healthy ipsilateral kidney, defined as the ipsilateral renal volume receiving 50% of the prescribed dose (V50%).
4 secondary outcomes
Evaluate the current treatment, including the benefit of online adaptive radiotherapy
Time frame: Day 1 planning CTs. Approximately day 14: start radiotherapy (3 times per week). At each fraction: CBCT. At completion of treatment (at approximately day 30) planning for adapted and non-adapted plans
Investigate treatment fraction reduction
Time frame: At day 1 planning CTs are acquired for treatment planning. These will be used for treatment planning for simulated fraction schedules using standard and novel motion management
Change From Baseline in Tumor Contrast Enhancement on Photon-Counting CT
Time frame: Baseline (pre-treatment) and follow-up at 3, 6, and 12 months after completion of treatment
Change From Baseline in Tumor Iodine Concentration on Photon-Counting CT
Time frame: Baseline (pre-treatment) and follow-up at 3, 6, and 12 months after completion of treatment
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 8 Apr 2026.
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Renal Cell Carcinoma
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 study testing Additional radiation due to imaging in people with Renal Cell Carcinoma (RCC), run by Erasmus Medical Center at 1 site in Netherlands.
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 5 inclusion and 1 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 8 Apr 2026. 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 Netherlands. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of renal dose (time frame: At day 1 planning CTs are acquired for treatment planning. These scans will be used to make a treatment planning with standard motion management and a treatment planning will be made using novel motion management. Both plans will be compared.). 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 8 Apr 2026.