NCT06995664 Partial Volume High-Dose Irradiation in Renal Cell Carcinoma for Intra-TUmoural Control ALongside Current Management
| NCT ID | NCT06995664 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Royal Marsden NHS Foundation Trust |
| Condition | Renal Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2023-03-27 |
| Primary Completion | 2025-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2023-03-27 with a primary completion date of 2025-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06995664 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Renal Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06995664 currently recruiting?
Yes, NCT06995664 is actively recruiting participants. Contact the research team at VIRTUAL.Trial@rmh.nhs.uk for enrollment information.
Where is the NCT06995664 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT06995664 clinical trial?
NCT06995664 is sponsored by Royal Marsden NHS Foundation Trust. The trial plans to enroll 24 participants.