CBCT Guided Markerless SBRT for Renal Cell Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Additional radiation due to imaging.
- Who it may be relevant to
- Registry conditions: Renal Cell Carcinoma (RCC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Organ Sparing Marker-less CBCT-guided Stereotactic Adaptive Radiotherapy for Primary Non-metastasized Renal Tumors
Overview
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.
Interventions
- Radiation Additional radiation due to imaging
Additional imaging will be done using CT, therefore the patient will receive additional radiation dose
Primary outcome measures
- 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.]
Secondary outcome measures (4)
- 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]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- Erasmus MC — Rotterdam
Identifiers
NCT: NCT07402109 · NL-010279