Partial Volume High-Dose Irradiation in Renal Cell Carcinoma for Intra-TUmoural Control ALongside Current Management

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

Eligibility

Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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)
* Co-morbidities or any psychological, familial, sociological or geographical condition which may preclude ability to undergo/attend investigations, treatment or follow-up
* Other active primary cancer
* Pregnant or lactating
* Requiring ongoing treatment with a concomitant medication, which is contraindicated alongside radiotherapy (e.g. methotrexate)

Conditions3

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