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NCT Number: NCT07402109

CBCT Guided Markerless SBRT for Renal Cell Cancer

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

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Key information

Conditions

Renal Cell Carcinoma (RCC) Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasmus MC

Rotterdam, South Holland, 3000CA, Netherlands

Location status: Recruiting

Location contact

Department of radiotherapy

CONTACT

[email protected]

010-7041013

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Previous high-dose radiotherapy in the region of the kidney

Treatment and study plan

Additional radiation due to imaging

Radiation

Additional imaging will be done using CT, therefore the patient will receive additional radiation dose

Primary outcomes

  1. 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%).

Secondary outcomes

  1. 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

    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

  2. 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

    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

  3. 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

    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.

  4. 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

    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.

Other outcomes

  1. Monitor side effects

    Time frame: During treatment and at 3, 6, and 12 months after completion of treatment

    Side-effects are assessed during treatment and follow up, according to Common Terminology Criteria for Adverse Events version 5 (CTC-AE version 5).

  2. Monitor renal function

    Time frame: At 3, 6, and 12 months after treatment, followed by biannual evaluations at the referring center (referring urologist) in the second year and annual assessments in the third and fourth years

    Renal function changes will be measured using estimated glomerular filtration rate (eGFR)

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

Organ Sparing Marker-less CBCT-guided Stereotactic Adaptive Radiotherapy for Primary Non-metastasized Renal Tumors

Acronym: CT-STARRS

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Feb 11, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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