Actively Recruiting
Partial Volume High-Dose Irradiation in Renal Cell Carcinoma for Intra-TUmoural Control ALongside Current Management
Led by Royal Marsden NHS Foundation Trust · Updated on 2025-05-29
24
Participants Needed
1
Research Sites
161 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Partial Volume High-Dose Irradiation in Renal Cell Carcinoma for Intra-TUmoural Control ALongside Current Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed renal cell carcinoma (RCC) or clinically consistent with RCC as per multidisciplinary team diagnosis
- Not suitable for surgical resection, metastasectomy, or ablative therapy due to tumor or patient factors
- Extracranial sites requiring radiotherapy as decided by clinician
- Age 18 years or older
- Karnofsky Performance Status 50 or higher
- Adequate baseline organ function for irradiation site
- Hemoglobin 90 g/dl or higher
- Platelets 50 or higher
- Bilirubin less than 3 times upper limit of normal
- INR less than 1.4 or correctable with vitamin K
- AST or ALT less than 5 times normal range
- Creatinine less than 200 umol/L or on dialysis (not eligible for dynamic contrast enhanced MRI)
- Concurrent systemic therapy allowed
- Ability to understand and sign informed consent
- Able to undergo all required staging and follow-up investigations
- Negative pregnancy test for women of childbearing potential
You will not qualify if you...
- Expected prognosis less than 6 months
- Uncontrolled intracranial metastases
- Prior radiotherapy preventing further feasible radiotherapy
- Unable to have necessary radiotherapy planning or related investigations
- Co-morbidities or psychological, familial, sociological, or geographical conditions preventing treatment or follow-up
- Other active primary cancer
- Pregnant or lactating
- Requiring treatment with medication contraindicated with radiotherapy, such as methotrexate
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Royal Marsden NHSFT
London, United Kingdom, SW3 6JJ
Actively Recruiting
Research Team
H
Harshani Green
CONTACT
S
Sijy Pillai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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