Partial Volume High-Dose Irradiation in Renal Cell Carcinoma for Intra-TUmoural Control ALongside Current Management

Launched by ROYAL MARSDEN NHS FOUNDATION TRUST · May 21, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new way to treat kidney cancer, specifically renal cell carcinoma (RCC), by comparing two types of radiation therapy. One group of patients will receive the standard treatment, which involves a lower dose of radiation given over 10 sessions in two weeks. The other group will receive a higher dose of radiation given in fewer sessions, spaced out over the same period. The goal is to see if the higher dose can be given safely and effectively, and to understand how it compares to the standard treatment.

To participate in this trial, patients must be at least 18 years old and have confirmed kidney cancer that cannot be surgically removed. They should have a reasonable level of health, as indicated by their ability to perform daily activities. Patients who have other serious health issues, uncontrolled brain metastases, or who are pregnant or breastfeeding are not eligible. Those who join the study can expect to undergo radiation therapy and regular follow-ups to monitor their health. The trial is currently looking for at least 24 participants, and it aims to provide valuable insights into better treatment options for kidney cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically confirmed renal cell carcinoma (RCC) (histological confirmation of metastasis not required) or clinically consistent with RCC as per multidisciplinary team (MDT) diagnosis.
• • Not suitable for surgical resection, metastasectomy or ablative therapy due to tumour or patient factors
• • All extracranial sites which clinically require radiotherapy (as per clinician discretion)
• • Age ≥18 years
• • Karnofsky Performance Status (KPS) ≥50
• • Adequate baseline organ function applicable to site-of irradiation
• • Haemaglobin ≥90g/dl
• • Platelets ≥50
• • Bilirubin \<3x ULN
• • INR \<1.4 or correctable with vitamin K
• • AST or ALT \<5x normal range
• • Creatinine \<200umol/L (or established on dialysis). Note patients on dialysis are unable to have dynamic contrast enhanced MRI.
• • The use of concurrent systemic therapy is acceptable
• • Ability of the research subject to understand and the willingness to sign a written informed consent document
• • Able to undergo all mandated staging and follow-up investigations
• • Negative pregnancy test (for women of childbearing potential)
• Exclusion Criteria:
• • Expected prognosis \<6 months
• • Uncontrolled intracranial metastases
• • Previous radiotherapy, such that the delivery of further radiotherapy is not feasible
• • Unable to have necessary radiotherapy planning, radiotherapy related investigations/fiducials (if required)
• • Co-morbidities or any psychological, familial, sociological or geographical condition which may preclude ability to undergo/attend investigations, treatment or follow-up
• • Other active primary cancer
• • Pregnant or lactating
• • Requiring ongoing treatment with a concomitant medication, which is contraindicated alongside radiotherapy (e.g. methotrexate)