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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoyal Marsden NHS Foundation Trust

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

Treatment groups

24 Participants
are divided into 2 treatment groups