Status:
RECRUITING
Partial Volume High-Dose Irradiation in Renal Cell Carcinoma for Intra-TUmoural Control ALongside Current Management
Lead Sponsor:
Royal Marsden NHS Foundation Trust
Conditions:
Renal Cell Carcinoma
Renal Cell Carcinoma Metastatic
Eligibility:
All Genders
18+ years
Phase:
NA
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. ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06995664
Start Date
March 27 2023
End Date
May 1 2026
Last Update
May 29 2025
Active Locations (1)
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1
The Royal Marsden NHSFT
London, United Kingdom, SW3 6JJ