NCT05941169

Brief 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for not_applicable

Timeline
59mo left

Started Aug 2023

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Aug 2023Apr 2031

First Submitted

Initial submission to the registry

June 22, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
20 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2031

Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

6.7 years

First QC Date

June 22, 2023

Last Update Submit

July 3, 2023

Conditions

Renal Cell Carcinoma

Keywords

Cytoreductive NephrectomyImmunotherapyTyrosine Kinase Inhibitor

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    Overall Survival Using Kaplan Meier Survival analysis

    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)

    Post operative follow-up period during 5 years

  • Surgical morbidity outcomes using Clavien Dindo classification of surgical morbidity

    Post operative follow-up period during 5 years

Other Outcomes (1)

  • Clinical data and annotated tissue for translational research into mechanisms of treatment response and resistance.

    post-operative follow-up period during 5 years

Study Arms (2)

Cytoreductive Nephrectomy

EXPERIMENTAL

Cytoreductive Nephrectomy within 6 months to 1 year after start systemic therapy for metastatic Renal Cell Carcinoma

Procedure: Cytoreductive Nephrectomy

Standard of Care

NO INTERVENTION

Standard of Care for metastatic Renal Cell Carcinoma

Interventions

Cytoreductive NephrectomyPROCEDURE

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

Cytoreductive Nephrectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 39483517DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Adriaan Bins, MD PhD

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adriaan Bins, MD PhD

CONTACT

020 5665955a.d.bins@amsterdamumc.nl

Axel Bex, MD PhD

CONTACT

020 512 9111a.bex@nki.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 22, 2023

First Posted

July 12, 2023

Study Start

August 1, 2023

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

April 1, 2031

Last Updated

July 12, 2023

Record last verified: 2023-07