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NCT01897454 · ClinicalTrials.gov registry record · Phase 2
Gemcitabine Hydrochloride, and Radiation Therapy in Patients With Borderline Resectable Pancreatic Cancer
A Phase 2 study, sponsored by Albert Einstein College of Medicine.
- Terminated
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT01897454: Clinical Trial Phase 2 study, sponsored by Albert Einstein College of Medicine.
NCT01897454 is a Phase 2 study that was terminated before completion, run by Albert Einstein College of Medicine. The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01897454, a Phase 2 study, was terminated before completion, sponsored by Albert Einstein College of Medicine.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study Summary
This phase II trial studies how well combination chemotherapy, gemcitabine hydrochloride, and radiation therapy before surgery works in treating patients with pancreatic cancer that has not spread to other places in the body and can be removed by surgery. Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, irinotecan hydrochloride, oxaliplatin, and gemcitabine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Fluorouracil, irinotecan hydrochloride, and gemcitabine hydrochloride may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy and gemcitabine hydrochloride with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Primary Outcome
The percentage of participants achieving R0 resection, defined as the absence of gross and microscopic tumor involvement in the resection margins, will be determined for those participants who receive at least one cycle of FOLFIRINOX chemotherapy. A 90% confidence interval will be determined.
Interventions
- DRUG Fluorouracil
- RADIATION Intensity-Modulated Radiation Therapy
- DRUG Irinotecan Hydrochloride
- DRUG Gemcitabine Hydrochloride
- DRUG Leucovorin Calcium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2012-01-27 |
| Est. Completion | 2021-11-01 |
| Phase | Phase 2 |
Why NCT01897454 stopped before completion
NCT01897454 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 5 interventions - of which Fluorouracil is the first listed.
NCT01897454 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01897454 about?
NCT01897454 is a clinical study titled "Gemcitabine Hydrochloride, and Radiation Therapy in Patients With Borderline Resectable Pancreatic Cancer". This phase II trial studies how well combination chemotherapy, gemcitabine hydrochloride, and radiation therapy before surgery works in treating patients with pancreatic cancer that has not spread to other places in the body and can be removed by surgery. Drugs used in chemotherapy, such as fluorour...
What is the current status of trial NCT01897454?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2012-01-27. Estimated completion is 2021-11-01.
What interventions are being tested in trial NCT01897454?
The interventions under investigation include: Fluorouracil (DRUG), Intensity-Modulated Radiation Therapy (RADIATION), Irinotecan Hydrochloride (DRUG), Gemcitabine Hydrochloride (DRUG), Leucovorin Calcium (DRUG).
Who is sponsoring clinical trial NCT01897454?
This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01897454's enrollment target sits among peer trials
23 1784th of 2000 higher than 211 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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