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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Additional imaging | Experimental | Additional CBCT scans will be made after each fraction, follow-up will be done using photon counting CT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Additional radiation due to imaging | Radiation | Additional imaging will be done using CT, therefore the patient will receive additional radiation dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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%). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Monitor side effects | Side-effects are assessed during treatment and follow up, according to Common Terminology Criteria for Adverse Events version 5 (CTC-AE version 5). | During treatment and at 3, 6, and 12 months after completion of treatment |
| Monitor renal function |
Inclusion Criteria:
Written informed consent
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus MC | Recruiting | Rotterdam | South Holland | 3000CA | Netherlands |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| 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 | 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. | 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. | Baseline (pre-treatment) and follow-up at 3, 6, and 12 months after completion of treatment |
Renal function changes will be measured using estimated glomerular filtration rate (eGFR) |
| 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 |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |