Partial Volume High-Dose Irradiation in Renal Cell Carcinoma for Intra-TUmoural Control ALongside Current Management
NCT ID: NCT06995664
Last Updated: 2025-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
24 participants
INTERVENTIONAL
2023-03-27
2026-05-31
Brief Summary
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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
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Detailed Description
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AIMS 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
Secondary aim
* To report acute and late toxicity in both treatment groups
* To demonstrate completion of quality of life (QOL) validated EORTC forms by patients under study
STUDY DESIGN
* Randomised 1:1
* The study is unblinded for the trial investigators and participants.
VISITS (in line with routine standard care):
* 1 Pre-treatment appointment
* 1 CT planning scan (immobilisation/mould room as required dependent on anatomical site)
* 10 radiotherapy treatment appointments (Control Arm) / 5 radiotherapy treatment appointments (Experimental Arm)
* 2 on-treat clinic reviews (week 1 and week 2)
* End of Treatment/Safety follow up (4 weeks post-radiotherapy)
* Follow-up at 3 months, 6 months, and 12 months
INVESTIGATIONS
* Quality of Life questionnaires
* Blood tests
* Clinical/Physical Examination
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
Standard palliative-dose radiotherapy, 30Gy in 10 fractions in 3Gy per fraction over 2 weeks
No interventions assigned to this group
Experimental / High-dose
High-dose radiotherapy, 30Gy in 5 fractions in 6Gy per fraction on alternate days/2-3 fractions a week over 2 weeks
radiotherapy
External Beam Radiotherapy - hypofractionated, short radiotherapy regime of 30Gy in 5 fractions (6Gy per fraction) delivered on alternate days over 2 weeks
Interventions
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radiotherapy
External Beam Radiotherapy - hypofractionated, short radiotherapy regime of 30Gy in 5 fractions (6Gy per fraction) delivered on alternate days over 2 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Royal Marsden NHS Foundation Trust
OTHER
Responsible Party
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Locations
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The Royal Marsden NHSFT
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CCR5652
Identifier Type: -
Identifier Source: org_study_id
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