Renal Cell Carcinoma (RCC)
Conditions
Brief 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
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
RADIATIONAdditional radiation due to imaging
Additional imaging will be done using CT, therefore the patient will receive additional radiation dose
Sponsors
Erasmus Medical Center
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of renal dose | 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the current treatment, including the benefit of online adaptive radiotherapy | 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 |
| Investigate treatment fraction reduction | 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 |
| Change From Baseline in Tumor Contrast Enhancement on Photon-Counting CT | 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. |
| Change From Baseline in Tumor Iodine Concentration on Photon-Counting CT | 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. |
Countries
Netherlands
Outcome results
None listed