Partial Volume High-Dose Irradiation in Renal Cell Carcinoma for Intra-TUmoural Control ALongside Current Management
NCT06995664 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2025-05-29
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
Interventions
- PROCEDURE
-
radiotherapy
External Beam Radiotherapy - hypofractionated, short radiotherapy regime of 30Gy in 5 fractions (6Gy per fraction) delivered on alternate days over 2 weeks
Sponsors & Collaborators
-
Royal Marsden NHS Foundation Trust
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-27
- Primary Completion
- 2025-05-31
- Completion
- 2026-05-31
Countries
- United Kingdom
Study Locations
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