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