High-dose radiotherapy for renal cell carcinoma treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The Royal Marsden NHSFT
  London, United Kingdom Recruiting

Study contacts

• Study coordinator: Harshani Green
• Email: VIRTUAL.Trial@rmh.nhs.uk
• Phone: 020 7811 8116

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.