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NCT05806931 · ClinicalTrials.gov registry record · Phase 2
Sequential TAS-OX Alternating With TAS-IRI Plus Bevacizumab for Late-Line Metastatic Colorectal Cancer
A Phase 2 study of Colon Cancer and Rectal Cancer, sponsored by Rutgers, The State University of New Jersey.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 9
- Study locations
NCT05806931: Recruiting Phase 2 study of Colon Cancer and Rectal Cancer, sponsored by Rutgers, The State University of New Jersey.
NCT05806931 is a Phase 2 study of Colon Cancer and Rectal Cancer that is actively recruiting participants, run by Rutgers, The State University of New Jersey. The registered enrollment target is 50 participants, below the 4,456-participant average among 97 other Colon Cancer trials with a reported enrollment target (99% lower). The trial reports 9 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05806931, a Phase 2 study of Colon Cancer and Rectal Cancer, is actively recruiting participants, sponsored by Rutgers, The State University of New Jersey.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 9
- Study locations
Study Summary
This study is to evaluate the disease control rate and time to progression of the sequential combination of oxaliplatin with an alternative anti-metabolite Trifluridine/tipiracil hydrochloride mixture, TAS-102,(TAS-OX) as well as irinotecan in combination with TAS-102 oxaliplatin(TAS-OX) + Bevacizumab in late-line metastatic colorectal cancer (mCRC)
Primary Outcome
Defined as the percentage of patients who have achieved complete response (CR), partial response (PR) and stable disease (SD). The disease control rate will be calculated along with 95% confidence interval. As Simon's two stage design is used in the study, 95% CI will be calculated for the two-stage nature of the study design. Response will be determined by independent radiologists using the RECIST criteria.
Conditions Studied
Interventions
- DRUG TAS-102, oxaliplatin, irinotecan with bevacizumab
Study Locations (9)
New Jersey
- Trinitas Hospital and Comprehensive Cancer Center - Elizabeth
- RWJBarnabas Health Jersey City Medical Center - Jersey City
- RWJBarnabas Health - Monmouth Medical Center Southern Campus - Lakewood
- Cooperman Barnabas Medical Center (Saint Barnabas Medical Center) - Livingston
- RWJBarnabas Health - Monmouth Medical Center - Long Branch
- Rutgers Cancer Institute of New Jersey - New Brunswick
- RWJBarnabas Health - Robert Wood Johnson University Hospital - New Brunswick
- RWJBarnabas Health - Robert Wood Johnson University Hospital - Somerset
- RWJBarnabas Health - Community Medical Center - Toms River
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2023-05-17 |
| Est. Completion | 2027-05-01 |
| Phase | Phase 2 |
What NCT05806931 shows while recruiting
NCT05806931 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 4,456-participant average among 97 other Colon Cancer trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Colon Cancer appearing as the primary indexed condition, and to 1 intervention - of which TAS-102, oxaliplatin, irinotecan with bevacizumab is the first listed.
NCT05806931 lists 9 locations in 1 state (New Jersey).
Frequently Asked Questions
What is clinical trial NCT05806931 about?
NCT05806931 is a clinical study titled "Sequential TAS-OX Alternating With TAS-IRI Plus Bevacizumab for Late-Line Metastatic Colorectal Cancer". This study is to evaluate the disease control rate and time to progression of the sequential combination of oxaliplatin with an alternative anti-metabolite Trifluridine/tipiracil hydrochloride mixture, TAS-102,(TAS-OX) as well as irinotecan in combination with TAS-102 oxaliplatin(TAS-OX) + Bevacizum...
What is the current status of trial NCT05806931?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2023-05-17. Estimated completion is 2027-05-01.
What conditions does trial NCT05806931 study?
This clinical trial studies the following conditions: Colon Cancer, Rectal Cancer.
What interventions are being tested in trial NCT05806931?
The interventions under investigation include: TAS-102, oxaliplatin, irinotecan with bevacizumab (DRUG).
Who is sponsoring clinical trial NCT05806931?
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 NCT05806931 being conducted?
This trial has 9 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colon Cancer
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 NCT05806931's enrollment target sits among peer trials
50 68th of 97 higher than 27 of 97 other Colon Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colon Cancer 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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