High-dose radiotherapy for renal cell carcinoma treatment
Partial Volume High-Dose Irradiation in Renal Cell Carcinoma for Intra-TUmoural Control ALongside Current Management - a Randomised Feasibility Study
This study is testing whether a higher dose of radiation therapy can be a better option for people with kidney cancer compared to the standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Royal Marsden NHS Foundation Trust Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (London) |
| Trial ID | NCT06995664 on ClinicalTrials.gov |
What this trial studies
This study is a prospective, randomized feasibility assessment comparing standard palliative dose radiotherapy to a high-dose hypofractionated radiotherapy regimen in patients with localized or metastatic renal cell carcinoma. The primary aim is to evaluate the feasibility of recruiting patients for this comparison, with a target enrollment of 24 participants divided equally between the two treatment arms. Participants will undergo a series of radiotherapy sessions and will be monitored for acute and late toxicity, as well as quality of life through validated questionnaires.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed renal cell carcinoma who are not suitable for surgical resection or other ablative therapies.
Not a fit: Patients with renal cell carcinoma who are candidates for surgical resection or have contraindications to radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective radiotherapy option for patients with renal cell carcinoma, potentially improving their treatment outcomes.
How similar studies have performed: While this approach is novel in the context of renal cell carcinoma, similar studies in other cancers have shown promising results with high-dose hypofractionated radiotherapy.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
London
- The Royal Marsden NHSFT — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Harshani Green
- Email: VIRTUAL.Trial@rmh.nhs.uk
- Phone: 020 7811 8116
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.