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NCT01652196 · ClinicalTrials.gov registry record · Phase 2
Aflibercept and FOLFOX6 Treatment for Previously Untreated Stage IV Colorectal Cancer
A Phase 2 study, sponsored by John Hays.
- Completed
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
NCT01652196: Completed Phase 2 study, sponsored by John Hays.
NCT01652196 is a Phase 2 study that has completed, run by John Hays. The registered enrollment target is 56 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01652196, a Phase 2 study, has completed, sponsored by John Hays.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
Study Summary
This phase II trial studies how well giving aflibercept together with combination chemotherapy works in treating patients with previously untreated colon or rectal cancer that is metastatic or locally advanced and cannot be removed by surgery. Aflibercept may stop the growth of colon or rectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving aflibercept together with combination chemotherapy may kill more tumor cells
Primary Outcome
Assuming that the number of treatment successes (alive and progression-free) is binomially distributed, proportion estimates along with their corresponding exact 95% confidence intervals will be calculated.
Interventions
- DRUG oxaliplatin
- DRUG fluorouracil
- DRUG leucovorin
- OTHER Correlative Studies
- BIOLOGICAL aflibercept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2012-11-14 |
| Est. Completion | 2022-08-30 |
| Phase | Phase 2 |
What the finished NCT01652196 record still lists
NCT01652196 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 5 interventions - of which oxaliplatin is the first listed.
NCT01652196 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01652196 about?
NCT01652196 is a clinical study titled "Aflibercept and FOLFOX6 Treatment for Previously Untreated Stage IV Colorectal Cancer". This phase II trial studies how well giving aflibercept together with combination chemotherapy works in treating patients with previously untreated colon or rectal cancer that is metastatic or locally advanced and cannot be removed by surgery. Aflibercept may stop the growth of colon or rectal cance...
What is the current status of trial NCT01652196?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2012-11-14. Estimated completion is 2022-08-30.
What interventions are being tested in trial NCT01652196?
The interventions under investigation include: oxaliplatin (DRUG), fluorouracil (DRUG), leucovorin (DRUG), Correlative Studies (OTHER), aflibercept (BIOLOGICAL).
Who is sponsoring clinical trial NCT01652196?
This trial is sponsored by John Hays, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01652196's enrollment target sits among peer trials
56 1146th of 2000 higher than 848 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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