Partial Volume High-Dose Irradiation in Renal Cell Carcinoma for Intra-TUmoural Control ALongside Current Management (VIRTUAL)

Royal Marsden NHS Foundation Trust

Status

Enrolling

Conditions

Renal Cell Carcinoma Metastatic

Renal Cell Carcinoma

Treatments

Procedure: radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06995664

CCR5652

Details and patient eligibility

About

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

Full 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

Enrollment

24 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)