NCT05941169Not yet recruiting
Primary Metastatic Renal Cell Carcinoma Treated With Immunecheckpoint Inhibitors and Cytoreductive Nephrectomy
A Prospective Study of Primary Metastatic Renal Cell Carcinoma Treated With Immunecheckpoint Inhibitors and Cytoreductive Nephrectomy vs Primary Tumour in Place
Source: ClinicalTrials.gov · Last updated 12 Jul 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 750 (estimated)
- First submitted
- 22 Jun 2023
- Start date
- 1 Aug 2023
- Primary completion date
- 1 Apr 2030
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Diseases
- Kidney cancer
- NCT number
- NCT05941169
What you commit to
- Study type: Interventional
- Planned participants: 750
- From 1 Aug 2023 to the primary completion date, 1 Apr 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- NA
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.