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

NCT06995664 | Recruiting

• 1 other identifier: CCR5652
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, randomised, feasibility study of patients with localised or metastatic renal cell carcinoma (RCC) comparing standard palliative dose radiotherapy to a high-dose hypofractionated regime. Primary aim

• To demonstrate feasibility of a randomised study comparing high-dose hypofractionated radiotherapy versus standard palliative dose radiotherapy in localised or metastatic renal cell carcinoma The aim is to recruit a minimum of 24 patients; 12 to the control arm and 12 to the high-dose regime. 2 treatment arms, no placebo:
• Control arm - standard palliative-dose radiotherapy, 30Gy in 10 fractions in 3Gy per fraction over 2 weeks
• High-dose arm - high-dose radiotherapy, 30Gy in 5 fractions in 6Gy per fraction on alternate days/2-3 fractions a week over 2 weeks

Conditions

Renal Cell Carcinoma; Renal Cell Carcinoma Metastatic

Keywords

standard palliative dose radiotherapy; high-dose hypofractionated radiotherapy; radiotherapy; unblinded

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  To demonstrate feasibility of recruitment (assessed by 35% of eligible patients accepting the offer of recruitment). To calculate the proportion of patients that accept the offer of recruitment to the study. The denominator is the number of eligible patients that have been approached for the study

  24 months

Secondary Outcomes (3)

• Secondary aim

  24 months

• Secondary aim

  24 months

• Secondary aim

  24 months

Study Arms (2)

Control

NO INTERVENTION

Standard palliative-dose radiotherapy, 30Gy in 10 fractions in 3Gy per fraction over 2 weeks

Experimental / High-dose

EXPERIMENTAL

High-dose radiotherapy, 30Gy in 5 fractions in 6Gy per fraction on alternate days/2-3 fractions a week over 2 weeks

Procedure: radiotherapy

Interventions

radiotherapy PROCEDURE

External Beam Radiotherapy - hypofractionated, short radiotherapy regime of 30Gy in 5 fractions (6Gy per fraction) delivered on alternate days over 2 weeks

Experimental / High-dose

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

The Royal Marsden NHSFT

London, SW3 6JJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Radiotherapy

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

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Harshani Green

CONTACT

020 7811 8116; VIRTUAL.Trial@rmh.nhs.uk

Sijy Pillai

CONTACT

020 7811 8116; VIRTUAL.Trial@rmh.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Unblinded to investigator and participants
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 treatment arms, patients randomised 1:1; no cross-over

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: May 29, 2025
• Study Start: March 27, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)