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NCT04294264 · ClinicalTrials.gov registry record · Phase 2
TAS-102 and Oxaliplatin for the Treatment of Refractory Stage IV Colon Cancer
A Phase 2 study of Metastatic Colorectal Carcinoma and Refractory Colorectal Carcinoma, sponsored by Rutgers, The State University of New Jersey.
- Active
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 6
- Study locations
NCT04294264: Active Phase 2 study of Metastatic Colorectal Carcinoma and Refractory Colorectal Carcinoma, sponsored by Rutgers, The State University of New Jersey.
NCT04294264 is a Phase 2 study of Metastatic Colorectal Carcinoma and Refractory Colorectal Carcinoma that is active but no longer recruiting, run by Rutgers, The State University of New Jersey. The registered enrollment target is 50 participants, below the 87-participant average among 22 other Metastatic Colorectal Carcinoma trials with a reported enrollment target (43% lower). The trial reports 6 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04294264, a Phase 2 study of Metastatic Colorectal Carcinoma and Refractory Colorectal Carcinoma, is active but no longer recruiting, sponsored by Rutgers, The State University of New Jersey.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 6
- Study locations
Study Summary
This phase II trial studies how well TAS-102 and oxaliplatin work in treating patients with stage IV colon cancer. Drugs used in chemotherapy, such as TAS-102 and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Primary Outcome
Response rate is defined as the percentage of subjects with a confirmed complete response (CR) or partial response (PR) by investigator assessment as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1. Response rate will be calculated by dose level. Descriptive statistics will be used to analyze efficacy data using historical data as reference.
Conditions Studied
Interventions
- DRUG Oxaliplatin
- DRUG Trifluridine and Tipiracil Hydrochloride
Study Locations (6)
New Jersey
- Trinitas Hospital and Comprehensive Cancer Center - Elizabeth
- RWJBarnabas Health - Monmouth Medical Center Southern Campus - Lakewood
- Saint Barnabas Medical Center - Livingston
- RWJBarnabas Health - Monmouth Medical Center - Long Branch
- Rutgers Cancer Institute of New Jersey - New Brunswick
- RWJBarnabas Health - Community Medical Center - Toms River
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2019-02-12 |
| Est. Completion | 2026-03-27 |
| Phase | Phase 2 |
What the registry record for NCT04294264 still lists
NCT04294264 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 87-participant average among 22 other Metastatic Colorectal Carcinoma trials with a reported enrollment target (43% lower).
The record links to 6 conditions, with Metastatic Colorectal Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Oxaliplatin is the first listed.
NCT04294264 lists 6 locations in 1 state (New Jersey).
Frequently Asked Questions
What is clinical trial NCT04294264 about?
NCT04294264 is a clinical study titled "TAS-102 and Oxaliplatin for the Treatment of Refractory Stage IV Colon Cancer". This phase II trial studies how well TAS-102 and oxaliplatin work in treating patients with stage IV colon cancer. Drugs used in chemotherapy, such as TAS-102 and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by...
What is the current status of trial NCT04294264?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2019-02-12. Estimated completion is 2026-03-27.
What conditions does trial NCT04294264 study?
This clinical trial studies the following conditions: Metastatic Colorectal Carcinoma, Refractory Colorectal Carcinoma, Recurrent Colon Carcinoma, Stage IV Colon Cancer AJCC v7, Stage IVA Colon Cancer AJCC v7.
What interventions are being tested in trial NCT04294264?
The interventions under investigation include: Oxaliplatin (DRUG), Trifluridine and Tipiracil Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT04294264?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04294264 being conducted?
This trial has 6 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04294264's enrollment target sits among peer trials
50 13th of 22 higher than 10 of 22 other Metastatic Colorectal Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Colorectal 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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