Overview
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
Description
HYPOTHESIS The investigators hypothesise that it is feasible to recruit to a study of localised and metastatic renal cell carcinoma comparing a high-dose short fractionation radiotherapy regime (30Gy in 5 fractions in alternate day fractions over 2 weeks) in comparison to the standard palliative dose-fractionation (30Gy in 10 fractions in daily fractions over 2 weeks).
AIMS 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
Secondary aim
- To report acute and late toxicity in both treatment groups
- To demonstrate completion of quality of life (QOL) validated EORTC forms by patients under study
STUDY DESIGN
- Randomised 1:1
- The study is unblinded for the trial investigators and participants.
VISITS (in line with routine standard care):
- 1 Pre-treatment appointment
- 1 CT planning scan (immobilisation/mould room as required dependent on anatomical site)
- 10 radiotherapy treatment appointments (Control Arm) / 5 radiotherapy treatment appointments (Experimental Arm)
- 2 on-treat clinic reviews (week 1 and week 2)
- End of Treatment/Safety follow up (4 weeks post-radiotherapy)
- Follow-up at 3 months, 6 months, and 12 months
INVESTIGATIONS
- Quality of Life questionnaires
- Blood tests
- Clinical/Physical Examination
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)