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Trial Title:
Primary Metastatic Renal Cell Carcinoma Treated With Immunecheckpoint Inhibitors and Cytoreductive Nephrectomy
NCT ID:
NCT05941169
Condition:
Renal Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Conditions: Keywords:
Cytoreductive Nephrectomy
Immunotherapy
Tyrosine Kinase Inhibitor
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomized controlled trial
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Cytoreductive Nephrectomy
Description:
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
Arm group label:
Cytoreductive Nephrectomy
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female patients age ≥ 18 years
2. 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.
3. Informed consent obtained for being offered future experimental interventions within
the PRO-RCC project.
4. Histologically confirmed diagnosis of metastatic clear cell, papillary or
chromophobe renal cell carcinoma of intermediate to poor risk, including sarcomatoid
features, with
5. World Health Organization (WHO) performance status of 0-1.
6. Surgical candidates based on surgeon and anesthetist assessment
7. Treatment with an IO combination (IO+IO or IO+TKI) as standard of care for
metastatic RCC
8. 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.
Exclusion Criteria:
NA
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
August 1, 2023
Completion date:
April 1, 2031
Lead sponsor:
Agency:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Agency class:
Other
Collaborator:
Agency:
Comprehensive Cancer Centre The Netherlands
Agency class:
Other
Source:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05941169
