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
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)
Parallel
radiotherapy
Procedure/SurgeryExternal Beam Radiotherapy - hypofractionated, short radiotherapy regime of 30Gy in 5 fractions (6Gy per fraction) delivered on alternate days over 2 weeks
Primary Outcome
To demonstrate feasibility of recruitment (assessed by 35% of eligible patients accepting the offer of recruitment). To calculate the proportion of patients that accept the offer of recruitment to the study. The denominator is the number of eligible patients that have been approached for the study
Secondary aim
To evaluate acute ≥Grade 3 CTCAE v5.0 toxicity by treatment group. 'Acute' is defined as less than or equal to 3 months post-completion of radiotherapy.
Secondary aim
To evaluate late ≥Grade 3 CTCAE v5.0 toxicity by treatment group. 'Late' is defined as over 3 months from completion of radiotherapy.
Secondary aim
To demonstrate completion of quality of life (QOL) validated EORTC forms by patients under study, by reporting upon the proportion of patients completing quality of life (QOL) questionnaires at baseline and follow up
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