NCT06995664

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Royal Marsden NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

HYPOTHESIS The investigators hypothesise that it is feasible to recruit to a study of localised and metastatic renal cell carcinoma comparing a high-dose short fractionation radiotherapy regime (30Gy in 5 fractions in alternate day fractions over 2 weeks) in comparison to the standard palliative dose-fractionation (30Gy in 10 fractions in daily fractions over 2 weeks). AIMS 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 Secondary aim * To report acute and late toxicity in both treatment groups * To demonstrate completion of quality of life (QOL) validated EORTC forms by patients under study STUDY DESIGN * Randomised 1:1 * The study is unblinded for the trial investigators and participants. VISITS (in line with routine standard care): * 1 Pre-treatment appointment * 1 CT planning scan (immobilisation/mould room as required dependent on anatomical site) * 10 radiotherapy treatment appointments (Control Arm) / 5 radiotherapy treatment appointments (Experimental Arm) * 2 on-treat clinic reviews (week 1 and week 2) * End of Treatment/Safety follow up (4 weeks post-radiotherapy) * Follow-up at 3 months, 6 months, and 12 months INVESTIGATIONS * Quality of Life questionnaires * Blood tests * Clinical/Physical Examination

Conditions

• Renal Cell Carcinoma
• Renal Cell Carcinoma Metastatic

Interventions

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

Timeline

• Start date: 2023-03-27
• Primary completion: 2025-05-01
• Completion: 2026-05-01
• First posted: 2025-05-29
• Last updated: 2025-05-29

Locations

1 site across 1 country: United Kingdom