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
A maximum of 700 patients with synchronous mRCC and absence of progression at metastatic sites following at least 6 mo of standard first-line ICI combination therapy will be assigned randomly to receive local treatment of the primary tumour (experimental arm) or SOC (control arm). The experimental intervention consists of (partial) CN, any form of ablative local therapy, or magnetic resonance imaging guided ablative stereotactic radiotherapy, performed within 6 mo and 1.5 yr after the start of systemic treatment.
Authors
- Paul C.M.S. Verhagen (ORCID: https://orcid.org/0000-0003-2565-6682)
- Adriaan D. Bins
- Britt B.M. Suelmann (ORCID: https://orcid.org/0000-0002-7155-3337)
- Bart Rikhof
- Johannes Berkhof (ORCID: https://orcid.org/0000-0003-2094-2380)
- Hilin Yildirim (ORCID: https://orcid.org/0000-0003-0965-7968)
- Paul Hamberg (ORCID: https://orcid.org/0000-0002-8223-0250)
- Metin Tascilar (ORCID: https://orcid.org/0000-0003-2055-7474)
- Orlane Figaroa (ORCID: https://orcid.org/0000-0002-5284-3515)
- Rob Kessels (ORCID: https://orcid.org/0000-0002-2479-3872)
- Hans M. Westgeest (ORCID: https://orcid.org/0000-0002-5735-3638)
- Axel Bex (ORCID: https://orcid.org/0000-0002-8499-2662)
- Maureen J.B. Aarts (ORCID: https://orcid.org/0000-0002-6381-1500)
- Patricia Zondervan (ORCID: https://orcid.org/0000-0003-0812-078X)
- Maartje Los
- Astrid van der Veldt
- Djura Piersma
Institutions
- Royal Free London NHS Foundation Trust (GB)
- Utrecht University (NL)
- Maastricht University Medical Centre (NL)
- Medisch Spectrum Twente (NL)
- Erasmus MC (NL)
- Medisch Centrum Leeuwarden (NL)
- The Netherlands Cancer Institute (NL)
- University Medical Center Utrecht (NL)
- Sint Franciscus Gasthuis (NL)
- St. Antonius Ziekenhuis (NL)
- Amphia Ziekenhuis (NL)
- Netherlands Comprehensive Cancer Organisation (NL)
- Isala (NL)
- Franciscus Vlietland (NL)
- Amsterdam University Medical Centers (NL)
- Vrije Universiteit Amsterdam (NL)
- University of Amsterdam (NL)
Publication Details
- Journal
- European Urology Open Science
- Published
- 2024-10-14
- DOI
- https://doi.org/10.1016/j.euros.2024.09.002
- Citations
- 3
- Primary Topic
- Renal cell carcinoma treatment
- Type
- article
- Field-Weighted Citation Impact
- 1.26