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New treatment option for Renal Cell Carcinoma
Official title Partial Volume High-Dose Irradiation in Renal Cell Carcinoma for Intra-TUmoural Control ALongside Current Management
ClinicalTrials.gov ID: NCT06995664
What this study is testing
- What it's testing
- 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.
- Time commitment: about 2 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed renal cell carcinoma (RCC) (histological confirmation of metastasis not required) or clinically consistent with RCC as per...
- 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
You likely can't join if
- 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...
- Other active primary cancer
See the full eligibility 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)
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.