Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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

Who May Be Eligible (Plain English)

Who May Qualify: - diagnosed by tissue sample (biopsy-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 - platelet count at least 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 willing to sign a consent form document - Able to undergo all mandated staging and follow-up investigations - Negative pregnancy test (for women of childbearing potential) Who Should NOT Join This Trial: - 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

PROCEDURE

radiotherapy

External Beam Radiotherapy - hypofractionated, short radiotherapy regime of 30Gy in 5 fractions (6Gy per fraction) delivered on alternate days over 2 weeks

Locations (1)

The Royal Marsden NHSFT
London, United Kingdom