A prospective study of primary metastatic renal cell carcinoma treated with immunecheckpoint inhibitors and cytoreductive nephrectomy vs primary tumour in place

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.

Cytoreductive nephrectomy

extent of the burden for patient in the control arm: not applicable
extend of the burden for patient in the therapy arm: admission (+- 3 days) and
surgery (cytoreductive nephrectomy) as life-prolonging therapy