Clinical trial NCT06995664: Partial Volume High-Dose Irradiation in Renal Cell Carcinoma for Intra-TUmoural Control ALongside Current Management
Official title: Partial Volume High-Dose Irradiation in Renal Cell Carcinoma for Intra-TUmoural Control ALongside Current Management - a Randomised Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Renal Cell Carcinoma
Renal Cell Carcinoma Metastatic
Keywords: standard palliative dose radiotherapy
high-dose hypofractionated radiotherapy
radiotherapy
unblinded
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 treatment arms, patients randomised 1:1; no cross-over
Primary purpose: TREATMENT

Brief summary: 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.

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

Detailed description: HYPOTHESIS The investigators hypothesise that it is feasible to recruit to a study of localised and metastatic renal cell carcinoma comparing a high-dose short fractionation radiotherapy regime (30Gy in 5 fractions in alternate day fractions over 2 weeks) in comparison to the standard palliative dose-fractionation (30Gy in 10 fractions in daily fractions over 2 weeks).

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

Eligibility 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)

Primary outcomes:
measure: Primary Outcome
timeFrame: 24 months
Secondary outcomes:
measure: Secondary aim
timeFrame: 24 months
measure: Secondary aim
timeFrame: 24 months
measure: Secondary aim
timeFrame: 24 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: The Royal Marsden NHSFT
Study officials:
References: