Actively Recruiting
Partial Volume High-Dose Irradiation in Renal Cell Carcinoma for Intra-Tumoural Control Alongside Current Management - a Randomised Feasibility Study
Led by Royal Marsden NHS Foundation Trust · Updated on 2025-05-29
24
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new radiotherapy approach for patients with localized or metastatic renal cell carcinoma (RCC). This study compares a high-dose short-course radiotherapy schedule to the standard palliative dose radiotherapy in order to understand the feasibility of recruiting patients for these treatments. The trial seeks to enroll at least 24 patients and aims to assess both treatment feasibility and quality of life outcomes. Participants are randomly assigned to one of two treatment groups. The control group receives standard radiotherapy consisting of 30 Gy delivered in 10 fractions over two weeks, while the experimental group receives a higher dose of 30 Gy in 5 fractions on alternate days over two weeks. The study involves pre-treatment planning scans, multiple radiotherapy sessions according to group assignment, and clinic reviews during treatment. Throughout the study, participants undergo quality of life assessments, blood tests, and physical examinations. Follow-up visits occur at 4 weeks post-treatment and then at 3, 6, and 12 months to monitor safety, toxicity, and patient well-being. The primary outcome focuses on feasibility over 24 months, alongside secondary aims to evaluate acute and late toxicity as well as quality of life completion rates. Participants are monitored closely to track these outcomes during the study period.
CONDITIONS
Brief Title
Partial Volume High-Dose Irradiation in Renal Cell Carcinoma for Intra-TUmoural Control ALongside Current Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed renal cell carcinoma or clinical diagnosis by multidisciplinary team
- Not suitable for surgery, metastasectomy, or ablative therapy due to tumor or patient factors
- All extracranial sites requiring radiotherapy as decided by clinician
- Age 18 years or older
- Karnofsky Performance Status of 50 or higher
- Adequate organ function related to site of irradiation
- Hemoglobin level 90 g/dl or higher
- Platelet count 50 or higher
- Bilirubin less than 3 times the upper limit of normal
- INR less than 1.4 or correctable with vitamin K
- AST or ALT less than 5 times normal range
- Creatinine less than 200 umol/L or established on dialysis
- Concurrent systemic therapy allowed
- Ability to understand and sign informed consent
- Able to complete all required staging and follow-up tests
- Negative pregnancy test for women of childbearing potential
You will not qualify if you...
- Expected prognosis less than 6 months
- Uncontrolled brain metastases
- Previous radiotherapy that prevents further treatment
- Unable to undergo necessary radiotherapy planning or related investigations
- Medical, psychological, or social conditions preventing treatment or follow-up
- Other active primary cancer
- Pregnant or breastfeeding
- Need for medications contraindicated with radiotherapy such as methotrexate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants receive either high-dose hypofractionated radiotherapy or standard palliative dose radiotherapy over 2 weeks.
5 or 10 radiotherapy treatment appointments plus 1 pre-treatment appointment and 1 CT planning scan
Duration - Up to 12 months
Participants attend follow-up visits to monitor safety, quality of life, and clinical outcomes after radiotherapy.
2 on-treatment clinic reviews, 1 safety follow-up visit at 4 weeks post-radiotherapy, and follow-up visits at 3 months, 6 months, and 12 months
Trial Site Locations
Total: 1 location
1
The Royal Marsden NHSFT
London, United Kingdom, SW3 6JJ
Actively Recruiting
Research Team
H
Harshani Green
S
Sijy Pillai
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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