CBCT Guided Markerless SBRT for Renal Cell Cancer
ConditionRenal Cell Carcinoma (RCC)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorErasmus Medical Center
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Previous high-dose radiotherapy in the region of the kidney
Trial design
Design model
Sequential
Treatments tested in this trial
Additional radiation due to imaging
RadiationAdditional imaging will be done using CT, therefore the patient will receive additional radiation dose
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Additional imagingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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%).
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 outcomes
1
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
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 plans2
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
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 management3
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.
Time frame
Baseline (pre-treatment) and follow-up at 3, 6, and 12 months after completion of treatment4
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.
Time frame
Baseline (pre-treatment) and follow-up at 3, 6, and 12 months after completion of treatmentOther outcomes
1
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).
Time frame
During treatment and at 3, 6, and 12 months after completion of treatment2
Monitor renal function
Renal function changes will be measured using estimated glomerular filtration rate (eGFR)
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov