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NCT04071223 · ClinicalTrials.gov registry record · Phase 2
Testing the Addition of a New Anti-cancer Drug, Radium-223 Dichloride, to the Usual Treatment (Cabozantinib) for Advanced Renal Cell Cancer That Has Spread to the Bone, RadiCaL Study
A Phase 2 study of Clear Cell Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 134
- Enrollment target
- 20
- Study locations
NCT04071223: Active Phase 2 study of Clear Cell Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
NCT04071223 is a Phase 2 study of Clear Cell Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 134 participants, below the 200-participant average among 45 other Clear Cell Renal Cell Carcinoma trials with a reported enrollment target (33% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04071223, a Phase 2 study of Clear Cell Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 134 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies whether adding radium-223 dichloride to the usual treatment, cabozantinib, improves outcomes in patients with renal cell cancer that has spread to the bone. Radioactive drugs such as radium-223 dichloride may directly target radiation to cancer cells and minimize harm to normal cells. Cabozantinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving radium-223 dichloride and cabozantinib may help lessen the pain and symptoms from renal cell cancer that has spread to the bone, compared to cabozantinib alone.
Primary Outcome
SSE-FS distribution will be estimated using the method of Kaplan-Meier by treatment arm. Comparison between the two arms will be performed using a one-sided log-rank test and one-sided p-value less than 0.025 will indicate that the experimental arm is superior to the control arm. SSE-FS will be censored at the date of last SSE assessment for those alive and SSE free. Hazard ratio (experimental over control arm) as well as two-sided 90% confidence interval (CI) for treatment will be estimated usi
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Bone Scan
- DRUG Cabozantinib S-malate
Study Locations (20)
Illinois
- Rush MD Anderson Cancer Center - Chicago
- University of Chicago Comprehensive Cancer Center - Chicago
- Cancer Care Specialists of Illinois - Decatur - Decatur
- Loyola University Medical Center - Maywood
- UC Comprehensive Cancer Center at Silver Cross - New Lenox
- Rush MD Anderson Cancer Center at Rush Oak Park - Oak Park
- University of Chicago Medicine-Orland Park - Orland Park
Iowa
- UI Health Care Mission Cancer and Blood - Ankeny Clinic - Ankeny
- Iowa Methodist Medical Center - Des Moines
- UI Health Care Mission Cancer and Blood - Des Moines Clinic - Des Moines
- University of Iowa/Holden Comprehensive Cancer Center - Iowa City
Kansas
- University of Kansas Cancer Center - Kansas City
- University of Kansas Cancer Center-Overland Park - Overland Park
- University of Kansas Hospital-Westwood Cancer Center - Westwood
Louisiana
- East Jefferson General Hospital - Metairie
- LSU Healthcare Network / Metairie Multi-Specialty Clinic - Metairie
- Tulane University School of Medicine - New Orleans
California
- UC San Diego Moores Cancer Center - La Jolla
- University of California Davis Comprehensive Cancer Center - Sacramento
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2020-07-29 |
| Est. Completion | 2026-10-01 |
| Phase | Phase 2 |
What the registry record for NCT04071223 still lists
NCT04071223 is an interventional study that assigns participants to a tested intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap, below the 200-participant average among 45 other Clear Cell Renal Cell Carcinoma trials with a reported enrollment target (33% lower).
The record links to 9 conditions, with Clear Cell Renal Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04071223 names 20 study sites across 6 states, led by Illinois, Iowa, Kansas.
Frequently Asked Questions
What is clinical trial NCT04071223 about?
NCT04071223 is a clinical study titled "Testing the Addition of a New Anti-cancer Drug, Radium-223 Dichloride, to the Usual Treatment (Cabozantinib) for Advanced Renal Cell Cancer That Has Spread to the Bone, RadiCaL Study". This phase II trial studies whether adding radium-223 dichloride to the usual treatment, cabozantinib, improves outcomes in patients with renal cell cancer that has spread to the bone. Radioactive drugs such as radium-223 dichloride may directly target radiation to cancer cells and minimize harm to ...
What is the current status of trial NCT04071223?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 134 participants. The study started on 2020-07-29. Estimated completion is 2026-10-01.
What conditions does trial NCT04071223 study?
This clinical trial studies the following conditions: Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8, Metastatic Malignant Neoplasm in the Bone, Advanced Renal Cell Carcinoma, Chromophobe Renal Cell Carcinoma.
What interventions are being tested in trial NCT04071223?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Bone Scan (PROCEDURE), Cabozantinib S-malate (DRUG).
Who is sponsoring clinical trial NCT04071223?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04071223 being conducted?
This trial has 20 study locations across Alabama, California, Illinois, Iowa, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04071223's enrollment target sits among peer trials
134 13th of 45 higher than 33 of 45 other Clear Cell Renal Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Clear Cell Renal Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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