CBCT-guided markerless stereotactic radiotherapy for kidney cancer
Organ Sparing Marker-less CBCT-guided Stereotactic Adaptive Radiotherapy for Primary Non-metastasized Renal Tumors
This project tests whether using CBCT imaging with breath-hold or surface-guided gating can deliver markerless SBRT more precisely for adults with non-metastatic kidney cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam, South Holland) |
| Trial ID | NCT07402109 on ClinicalTrials.gov |
What this trial studies
Forty patients with non-metastatic renal cell carcinoma will receive stereotactic body radiotherapy (SBRT) at a single center. The first 15 patients will have extra breath-hold cone-beam CT scans during treatment to measure how much the kidney and tumor move between and during fractions and to see if surface guidance can act as a reliable stand-in for target position. Data from that first cohort will be used to develop a motion-management approach, after which 25 additional patients will be treated using the new technique (breath-hold or gated delivery combined with surface guidance) without implanted markers. The protocol includes the extra imaging dose needed to obtain the CBCT scans and aims to minimize planning margins by achieving reproducible target positioning.
Who should consider this trial
Good fit: Adults (18+) with histologically proven or imaging-suspected non-metastatic renal cell carcinoma who are eligible for SBRT and can give informed consent are the intended participants.
Not a fit: Patients with metastatic disease, prior high-dose radiotherapy to the kidney region, or those unable to cooperate with breath-hold or surface-guidance procedures are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the approach could reduce radiation margins around the kidney tumor and lower unintended dose to normal kidney tissue, potentially reducing side effects while maintaining local control.
How similar studies have performed: SBRT has shown promising local control for renal cell carcinoma and surface-guided motion management has worked well in other tumor sites, but markerless CBCT-guided gating specifically for kidney tumors is a relatively novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rotterdam, South Holland
- Erasmus MC — Rotterdam, South Holland, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.