Renal Cell CarcinomaVIRTUALNCT06995664
Partial Volume High-Dose Irradiation in Renal Cell Carcinoma for Intra-TUmoural Control ALongside Current Management
A study testing radiotherapy in people with Renal Cell Carcinoma and Renal Cell Carcinoma Metastatic, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Renal Cell Carcinoma Metastatic
- What is being tested?
- radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Mar 2023to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
The Royal Marsden NHSFT
London, SW3 6JJ
Sijy Pillai, 020 7811 8116, VIRTUAL.Trial@rmh.nhs.uk
Vincent Khoo
About this study
Official title: Partial Volume High-Dose Irradiation in Renal Cell Carcinoma for Intra-TUmoural Control ALongside Current Management - a Randomised Feasibility Study
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
Read more
- 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
Read the 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
- Being tested
- radiotherapy
- Keywords
- standard palliative dose radiotherapy, high-dose hypofractionated radiotherapy, radiotherapy, unblinded
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapyProcedure or surgery
External Beam Radiotherapy - hypofractionated, short radiotherapy regime of 30Gy in 5 fractions (6Gy per fraction) delivered on alternate days over 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard palliative-dose radiotherapy, 30Gy in 10 fractions in 3Gy per fraction over 2 weeks |
| Experimental / High-dose | Experimental | High-dose radiotherapy, 30Gy in 5 fractions in 6Gy per fraction on alternate days/2-3 fractions a week over 2 weeks Receives: Procedure: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
To demonstrate feasibility of recruitment (assessed by 35% of eligible patients accepting the offer of recruitment). To calculate the proportion of patients that accept the offer of recruitment to the study. The denominator is the number of eligible patients that have been approached for the study
Measured: 24 months
Secondary outcomes (3)
Secondary aim
To evaluate acute ≥Grade 3 CTCAE v5.0 toxicity by treatment group. 'Acute' is defined as less than or equal to 3 months post-completion of radiotherapy.
Measured: 24 months
Secondary aim
To evaluate late ≥Grade 3 CTCAE v5.0 toxicity by treatment group. 'Late' is defined as over 3 months from completion of radiotherapy.
Measured: 24 months
Secondary aim
To demonstrate completion of quality of life (QOL) validated EORTC forms by patients under study, by reporting upon the proportion of patients completing quality of life (QOL) questionnaires at baseline and follow up
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start27 Mar 2023
- Primary completionMay 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 treatment arms, patients randomised 1:1; no cross-over
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995664
- Sponsor's protocol ID
- CCR5652
- Acronym
- VIRTUAL
- Status last verified
- May 2025
- First submitted
- 12 Aug 2024
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Volume High-Dose Irradiation in Renal Cell Carcinoma for Intra-TUmoural Control ALongside Current Management - a Randomised Feasibility Study
- ClinicalTrials.gov ID
- NCT06995664
- Acronym / sponsor ID
- VIRTUAL / CCR5652
- Keywords
- standard palliative dose radiotherapy, high-dose hypofractionated radiotherapy, radiotherapy, unblinded
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 treatment arms, patients randomised 1:1; no cross-over
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard palliative-dose radiotherapy, 30Gy in 10 fractions in 3Gy per fraction over 2 weeks |
| Experimental / High-dose | Experimental | Procedure: radiotherapyHigh-dose radiotherapy, 30Gy in 5 fractions in 6Gy per fraction on alternate days/2-3 fractions a week over 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiotherapyExternal Beam Radiotherapy - hypofractionated, short radiotherapy regime of 30Gy in 5 fractions (6Gy per fraction) delivered on alternate days over 2 weeks | Procedure or surgery | Experimental / High-dose |
Primary outcome
Primary Outcome
Time frame: 24 months
To demonstrate feasibility of recruitment (assessed by 35% of eligible patients accepting the offer of recruitment). To calculate the proportion of patients that accept the offer of recruitment to the study. The denominator is the number of eligible patients that have been approached for the study
3 secondary outcomes
Secondary aim
Time frame: 24 months
Secondary aim
Time frame: 24 months
Secondary aim
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No
Related trials for Renal Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiotherapy in people with Renal Cell Carcinoma and Renal Cell Carcinoma Metastatic, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Harshani Green (020 7811 8116, VIRTUAL.Trial@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.