Cytoreductive Nephrectomy for Metastatic Clear Cell Renal Cell Carcinoma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Metastatic Clear Cell Renal Cell Carcinoma+2 MoreCytoreductive Nephrectomy - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare immunotherapy plus surgery to immunotherapy alone to see if it is more effective in treating kidney cancer.

Eligible Conditions
  • Metastatic Clear Cell Renal Cell Carcinoma
  • Stage IV Renal Cell Carcinoma
  • Kidney Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 7 years

Year 7
Overall survival in subset who received assigned protocol treatment
Year 7
Overall survival
Year 7
Progression-free survival
Week 12
Change in maximum diameter of primary tumor
Up to 7 years
Objective response

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Arm 1: Continued Systemic Therapy Only
1 of 2
Arm 2: Nephrectomy and Continued Systemic Therapy
1 of 2

Active Control

Experimental Treatment

364 Total Participants · 2 Treatment Groups

Primary Treatment: Cytoreductive Nephrectomy · No Placebo Group · Phase 3

Arm 2: Nephrectomy and Continued Systemic Therapy
Procedure
Experimental Group · 1 Intervention: Cytoreductive Nephrectomy · Intervention Types: Procedure
Arm 1: Continued Systemic Therapy OnlyActiveComparator Group · 2 Interventions: Active Comparator, Cytoreductive Nephrectomy · Intervention Types: Drug, Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 7 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,085 Previous Clinical Trials
41,141,070 Total Patients Enrolled
6 Trials studying Metastatic Clear Cell Renal Cell Carcinoma
411 Patients Enrolled for Metastatic Clear Cell Renal Cell Carcinoma
Southwest Oncology GroupLead Sponsor
387 Previous Clinical Trials
262,589 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
People who have metastases that cause symptoms may have received palliative radiotherapy before they registered for the study, or they may receive palliative radiotherapy after they have registered for the study.
to be registered In order to register for the study, participants must have a primary tumor in place.
A computed tomography (CT) scan is a test that uses X-rays to create pictures of the inside of your body
Ultrasound, CT, and MRI scans of the abdomen and pelvis may be used to examine the organs and tissues in these areas
only if the primary tumor is clear cell or non-clear cell renal cell carcinoma
People who have never been treated for cancer must have scans documenting metastatic disease completed within 90 days prior to study registration.
and at Baseline People who have received treatment before must have scans documenting metastatic disease within 90 days before their first dose of systemic treatment and at the time of the study's baseline.
, including uncontrolled hypertension, significant coagulopathy, or an inability to provide autonomous consent
(STS) Participants must be offered the opportunity to participate in specimen banking
You must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.