At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- radiotherapy (procedure)
- How long the study runs
- Study runs about 38 months (dates as stated)
- About the drug or intervention
- radiotherapy — procedure: External Beam Radiotherapy - hypofractionated, short radiotherapy regime of 30Gy in 5 fractions (6Gy per fraction) delivered on alternate days over 2 weeks
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 24
- Started
- 2023-03-27
- Last checked
- 2025-05
Plain English Summary
What is this study?
- • Testing a new treatment for renal cell carcinoma
- • NA - 24 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with renal cell carcinoma
Where?
- • London - The Royal Marsden NHSFT
This is a simplified summary. Always discuss with your doctor before making any decisions.
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
More detail
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
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ radiotherapy (as per clinician discretion)
What the study is looking for
- ✓confirmed by a biopsy kidney cell carcinoma (RCC) (histological confirmation of metastasis not required) or...
- ✓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
Who cannot take part
- ✗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...
See the full criteria
Where Is This Study? (1 UK site)
The Royal Marsden NHSFT
London SW3 6JJ, United Kingdom
How to Get in Touch
Harshani Green
Sponsor contactCONTACT
Sijy Pillai
Sponsor contactCONTACT
