NCT06995664Recruiting
Partial Volume High-Dose Irradiation in Renal Cell Carcinoma for Intra-TUmoural Control ALongside Current Management
Partial Volume High-Dose Irradiation in Renal Cell Carcinoma for Intra-TUmoural Control ALongside Current Management - a Randomised Feasibility Study
Source: ClinicalTrials.gov · Last updated 29 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 12 Aug 2024
- Start date
- 27 Mar 2023
- Primary completion date
- May 2025
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Diseases
- Kidney cancer
- NCT number
- NCT06995664
What you commit to
- Study type: Interventional
- Planned participants: 24
- From 27 Mar 2023 to the primary completion date, May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous radiotherapy, such that the delivery of further radiotherapy is not feasible
- Unable to have necessary radiotherapy planning, radiotherapy related investigations/fiducials (if required)
- Requiring ongoing treatment with a concomitant medication, which is contraindicated alongside radiotherapy (e.g. methotrexate)
Other illness
- 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
Other
- Expected prognosis \<6 months
- Uncontrolled intracranial metastases
- Pregnant or lactating
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Royal Marsden NHSFT Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.