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

Sponsor: Royal Marsden NHS Foundation Trust

NCT ID: NCT06995664

View on ClinicalTrials.gov ↗

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

Renal Cell CarcinomaRenal Cell Carcinoma Metastatic

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What we know so far

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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
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)

Where Is This Study? (1 UK site)

The Royal Marsden NHSFT

London SW3 6JJ, United Kingdom

Recruiting
Site contact (verified)
Vincent KhooPrincipal Investigator

How to Get in Touch

Harshani Green

Sponsor contact

CONTACT

020 7811 8116 VIRTUAL.Trial@rmh.nhs.uk

Sijy Pillai

Sponsor contact

CONTACT

020 7811 8116 VIRTUAL.Trial@rmh.nhs.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-05