About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- radiotherapy