Renal Cell CarcinomaPrimerXNCT05941169
Primary Metastatic Renal Cell Carcinoma Treated With Immunecheckpoint Inhibitors and Cytoreductive Nephrectomy
A study testing Cytoreductive Nephrectomy in people with Renal Cell Carcinoma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Trial summary
The benefit of deferred Cytoreductive Nephrectomy (CN) has to be re-assessed in the context of IO +IO and IO + TKI systemic treatment. Given the benefit of CN in the setting of first generation immunotherapy, it is conceivable that both trials underestimated the benefit of CN, in absence of immunotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Cytoreductive Nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 1 Apr 2031
- 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
- Male or female patients age ≥ 18 years
- Signed and written informed consent Note: Written and signed informed consent will be obtained before any study procedures, including study-specific-screening procedures, has been performed.
- Informed consent obtained for being offered future experimental interventions within the PRO-RCC project.
- Histologically confirmed diagnosis of metastatic clear cell, papillary or chromophobe renal cell carcinoma of intermediate to poor risk, including sarcomatoid features, with
- World Health Organization (WHO) performance status of 0-1.
- Surgical candidates based on surgeon and anesthetist assessment
- Treatment with an IO combination (IO+IO or IO+TKI) as standard of care for metastatic RCC
- Absence of progression at metastatic sites at time of identification (6month after start of systemic first line treatment). 9) Primary tumor in situ 10) Participation in the PRO-RCC prospective cohort.
Who cannot join
- NA
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Study of Primary Metastatic Renal Cell Carcinoma Treated With Immunecheckpoint Inhibitors and Cytoreductive Nephrectomy vs Primary Tumour in Place
The benefit of deferred Cytoreductive Nephrectomy (CN) has to be re-assessed in the context of IO +IO and IO + TKI systemic treatment. Given the benefit of CN in the setting of first generation immunotherapy, it is conceivable that both trials underestimated the benefit of CN, in absence of immunotherapy.
Read the detailed description
In past years, much research has been done into the beneficial effects of cytoreductive nephrectomy in patients with metastatic renal cancer receiving systemic therapy with positive results. In the meantime systhemic therapy, and in particular immunotherapy, have changed. Patients with metastatic renal cancer are increasingly treated with immunocheckpoint inhibitors, but the effect of adding cytoreductive nephrectomy in this group of patients has not yet been investigated. The aim of this study is to investigate whether performing a cytoreductive nephrectomy has a beneficial effect on overall survival in patients with metastatic renal cancer receiving systemic therapy using immunocheckpoint inhibitors.
A randomized controlled trial. All eligible patients have already been enrolled in the PRO-RCC registry, a registry that collects prospective observational data, and have also given consent to be included in other studies as a control cohort. This design is called a TWiC (trial within cohort). After randomization, patients who are randomized into the therapy arm will receive a patient information via their treating physician. Upon participation, an informed consent will be signed and the patient will be scheduled for surgery.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Cytoreductive Nephrectomy
- Keywords
- Cytoreductive Nephrectomy, Immunotherapy, Tyrosine Kinase Inhibitor
- 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.
Cytoreductive NephrectomyProcedure or surgery
The experimental intervention consists of cytoreductive nephrectomy (CN) or any ablative local therapy within 6 months and 1 year after start of systemic treatment. All types of ablative local therapy are allowed as a substitute for CN
| Study group | Role | What they receive |
|---|---|---|
| Cytoreductive Nephrectomy | Experimental | Cytoreductive Nephrectomy within 6 months to 1 year after start systemic therapy for metastatic Renal Cell Carcinoma Receives: Procedure: Cytoreductive Nephrectomy |
| Standard of Care | No intervention | Standard of Care for metastatic Renal Cell Carcinoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall Survival Using Kaplan Meier Survival analysis
Measured: defined as time from randomization to death of any cause during 5 years of follow-up
Secondary outcomes (2)
Long term Quality of Life outcomes using validated EORTC Quality of Life Questionnaire (QLQ-C30)
using the Dutch validated EORTC Quality of Life Questionnaire (QLQ-C30)
Measured: Post operative follow-up period during 5 years
Surgical morbidity outcomes using Clavien Dindo classification of surgical morbidity
Clavien Dindo classification of surgical morbidity is used to classify morbidity outcomes
Measured: Post operative follow-up period during 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Apr 2030 (estimated)
- Study completion1 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Comprehensive Cancer Centre The Netherlands
- Responsible party
- Principal investigator, Adriaan D. Bins, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Adriaan Bins, MD PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941169
- Sponsor's protocol ID
- 83948
- Acronym
- PrimerX
- Status last verified
- Jul 2023
- First submitted
- 22 Jun 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Figaroa O, Zondervan P, Kessels R, Berkhof J, Aarts M, Hamberg P, Los M, Piersma D, Rikhof B, Suelmann B, Tascilar M, van der Veldt A, Verhagen P, Westgeest H, Yildirim H, Bex A, Bins A. PrimerX: A Bayesian Multistage Cohort Embedded Randomised Trial to Evaluate the Role of Deferred Local Therapy of the Primary Tumour in Combination with Immune Checkpoint Inhibitor-based First-line Therapy in Metastatic Renal Cell Carcinoma Patients. Eur Urol Open Sci. 2024 Oct 14;70:28-35. doi: 10.1016/j.euros.2024.09.002. eCollection 2024 Dec.
PubMed 39483517
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Primary Metastatic Renal Cell Carcinoma Treated With Immunecheckpoint Inhibitors and Cytoreductive Nephrectomy vs Primary Tumour in Place
- ClinicalTrials.gov ID
- NCT05941169
- Acronym / sponsor ID
- PrimerX / 83948
- Conditions
- Renal Cell Carcinoma
- Keywords
- Cytoreductive Nephrectomy, Immunotherapy, Tyrosine Kinase Inhibitor
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Comprehensive Cancer Centre The Netherlands
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 1 Apr 2031 (estimated)
- First posted
- 12 Jul 2023 (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.
The benefit of deferred Cytoreductive Nephrectomy (CN) has to be re-assessed in the context of IO +IO and IO + TKI systemic treatment. Given the benefit of CN in the setting of first generation immunotherapy, it is conceivable that both trials underestimated the benefit of CN, in absence of immunotherapy.
Detailed description
In past years, much research has been done into the beneficial effects of cytoreductive nephrectomy in patients with metastatic renal cancer receiving systemic therapy with positive results. In the meantime systhemic therapy, and in particular immunotherapy, have changed. Patients with metastatic renal cancer are increasingly treated with immunocheckpoint inhibitors, but the effect of adding cytoreductive nephrectomy in this group of patients has not yet been investigated. The aim of this study is to investigate whether performing a cytoreductive nephrectomy has a beneficial effect on overall survival in patients with metastatic renal cancer receiving systemic therapy using immunocheckpoint inhibitors.
A randomized controlled trial. All eligible patients have already been enrolled in the PRO-RCC registry, a registry that collects prospective observational data, and have also given consent to be included in other studies as a control cohort. This design is called a TWiC (trial within cohort). After randomization, patients who are randomized into the therapy arm will receive a patient information via their treating physician. Upon participation, an informed consent will be signed and the patient will be scheduled for surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Cytoreductive Nephrectomy | Experimental | Procedure: Cytoreductive NephrectomyCytoreductive Nephrectomy within 6 months to 1 year after start systemic therapy for metastatic Renal Cell Carcinoma |
| Standard of Care | No intervention | –Standard of Care for metastatic Renal Cell Carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patients age ≥ 18 years
- Signed and written informed consent Note: Written and signed informed consent will be obtained before any study procedures, including study-specific-screening procedures, has been performed.
- Informed consent obtained for being offered future experimental interventions within the PRO-RCC project.
- Histologically confirmed diagnosis of metastatic clear cell, papillary or chromophobe renal cell carcinoma of intermediate to poor risk, including sarcomatoid features, with
- World Health Organization (WHO) performance status of 0-1.
Key exclusion criteria (1 listed)
- NA
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 |
|---|---|---|
| Cytoreductive NephrectomyThe experimental intervention consists of cytoreductive nephrectomy (CN) or any ablative local therapy within 6 months and 1 year after start of systemic treatment. All types of ablative local therapy are allowed as a substitute for CN | Procedure or surgery | Cytoreductive Nephrectomy |
Primary outcome
Overall Survival
Time frame: defined as time from randomization to death of any cause during 5 years of follow-up
Overall Survival Using Kaplan Meier Survival analysis
2 secondary outcomes
Long term Quality of Life outcomes using validated EORTC Quality of Life Questionnaire (QLQ-C30)
Time frame: Post operative follow-up period during 5 years
Surgical morbidity outcomes using Clavien Dindo classification of surgical morbidity
Time frame: Post operative follow-up period during 5 years
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 12 Jul 2023.
- Derived from this study: PubMed 39483517Figaroa O, Zondervan P, Kessels R, Berkhof J, Aarts M, Hamberg P, Los M, Piersma D, Rikhof B, Suelmann B, Tascilar M, van der Veldt A, Verhagen P, Westgeest H, Yildirim H, Bex A, Bins A. PrimerX: A Bayesian Multistage Cohort Embedded Randomised Trial to Evaluate the Role of Deferred Local Therapy of the Primary Tumour in Combination with Immune Checkpoint Inhibitor-based First-line Therapy in Metastatic Renal Cell Carcinoma Patients. Eur Urol Open Sci. 2024 Oct 14;70:28-35. doi: 10.1016/j.euros.2024.09.002. eCollection 2024 Dec.
- Individual participant dataSharing planned: Undecided
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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.
Adriaan Bins, MD PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Questions about this trial
What is this clinical trial studying?
A study testing Cytoreductive Nephrectomy in people with Renal Cell Carcinoma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
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 8 inclusion and 1 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: opening soon, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Adriaan Bins, MD PhD (020 5665955, a.d.bins@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: defined as time from randomization to death of any cause during 5 years of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05941169, which also lists 1 linked publication.
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 12 Jul 2023.