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NCT04117945 · ClinicalTrials.gov registry record · Phase 2
Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer
A Phase 2 study of Stage IV Colorectal Cancer AJCC v8 and Stage III Colorectal Cancer AJCC v8, sponsored by Academic and Community Cancer Research United.
- Active
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
- 15
- Study locations
NCT04117945: Active Phase 2 study of Stage IV Colorectal Cancer AJCC v8 and Stage III Colorectal Cancer AJCC v8, sponsored by Academic and Community Cancer Research United.
NCT04117945 is a Phase 2 study of Stage IV Colorectal Cancer AJCC v8 and Stage III Colorectal Cancer AJCC v8 that is active but no longer recruiting, run by Academic and Community Cancer Research United. The registered enrollment target is 22 participants, below the 108-participant average among 22 other Stage IV Colorectal Cancer AJCC v8 trials with a reported enrollment target (80% lower). The trial reports 15 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04117945, a Phase 2 study of Stage IV Colorectal Cancer AJCC v8 and Stage III Colorectal Cancer AJCC v8, is active but no longer recruiting, sponsored by Academic and Community Cancer Research United.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
- 15
- Study locations
Study Summary
This phase II trial how well regorafenib and anti-EGFR therapy (cetuximab or panitumumab) works for the treatment of patients with colorectal cancer that cannot be removed by surgery (unresectable), has spread to nearby tissue or lymph nodes (locally advanced), or has spread to other places in the body (metastatic). Regorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab or panitumumab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The purpose of this research study is to compare the effects, good and/or bad, of taking regorafenib follow by cetuximab or panitumumab, to those that receive cetuximab or panitumumab before regorafenib.
Primary Outcome
The median OS and 95% confidence intervals in each arm will be reported.
Conditions Studied
Interventions
- BIOLOGICAL Cetuximab
- DRUG Regorafenib
- DRUG Irinotecan
- BIOLOGICAL Panitumumab
Study Locations (15)
Iowa
- University of Iowa/Holden Comprehensive Cancer Center - Iowa City
- Siouxland Regional Cancer Center - Sioux City
Arizona
- Mayo Clinic in Arizona - Scottsdale
California
- USC / Norris Comprehensive Cancer Center - Los Angeles
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Florida
- Mayo Clinic in Florida - Jacksonville
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
Illinois
- University of Chicago Comprehensive Cancer Center - Chicago
Kansas
- Cancer Center of Kansas - Wichita
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2020-03-03 |
| Est. Completion | 2025-03-31 |
| Phase | Phase 2 |
What the registry record for NCT04117945 still lists
NCT04117945 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 108-participant average among 22 other Stage IV Colorectal Cancer AJCC v8 trials with a reported enrollment target (80% lower).
The record links to 10 conditions, with Stage IV Colorectal Cancer AJCC v8 appearing as the primary indexed condition, and to 4 interventions - of which Cetuximab is the first listed.
NCT04117945 lists 15 locations in 14 states (Iowa, Arizona, California).
Frequently Asked Questions
What is clinical trial NCT04117945 about?
NCT04117945 is a clinical study titled "Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer". This phase II trial how well regorafenib and anti-EGFR therapy (cetuximab or panitumumab) works for the treatment of patients with colorectal cancer that cannot be removed by surgery (unresectable), has spread to nearby tissue or lymph nodes (locally advanced), or has spread to other places in the b...
What is the current status of trial NCT04117945?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2020-03-03. Estimated completion is 2025-03-31.
What conditions does trial NCT04117945 study?
This clinical trial studies the following conditions: Stage IV Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8, Metastatic Colorectal Adenocarcinoma, Stage IIIA Colorectal Cancer AJCC v8, Stage IIIB Colorectal Cancer AJCC v8.
What interventions are being tested in trial NCT04117945?
The interventions under investigation include: Cetuximab (BIOLOGICAL), Regorafenib (DRUG), Irinotecan (DRUG), Panitumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04117945?
This trial is sponsored by Academic and Community Cancer Research United, which has 42 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04117945 being conducted?
This trial has 15 study locations across Arizona, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage IV Colorectal Cancer AJCC v8
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 NCT04117945's enrollment target sits among peer trials
22 18th of 22 higher than 5 of 22 other Stage IV Colorectal Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Colorectal Cancer AJCC v8 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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