CBCT Guided Markerless SBRT for Renal Cell Cancer

NCT07402109 | Recruiting DMC

• 1 other identifier: NL-010279
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Renal Cell Carcinoma (RCC)

Outcome Measures

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%).

  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 (4)

• 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

• 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

• 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

• 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

Other Outcomes (2)

• Monitor side effects

  During treatment and at 3, 6, and 12 months after completion of treatment

• Monitor renal function

  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

Study Arms (1)

Additional imaging

EXPERIMENTAL

Additional CBCT scans will be made after each fraction, follow-up will be done using photon counting CT

Radiation: Additional radiation due to imaging

Interventions

Additional radiation due to imaging RADIATION

Additional imaging will be done using CT, therefore the patient will receive additional radiation dose

Additional imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous high-dose radiotherapy in the region of the kidney

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3000CA, Netherlands

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist, MD PhD, principal investigator

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: February 11, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

NL (1)