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NCT01523457 · ClinicalTrials.gov registry record · Phase 2
Study of Modified FOLFIRINOX in Advanced Pancreatic Cancer
A Phase 2 study of Pancreatic Cancer and Metastatic Pancreatic Cancer, sponsored by Yale University.
- Completed
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
- 1
- Study location
NCT01523457 is a Phase 2 study of Pancreatic Cancer and Metastatic Pancreatic Cancer that has completed, run by Yale University. The registered enrollment target is 75 participants, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01523457, a Phase 2 study of Pancreatic Cancer and Metastatic Pancreatic Cancer, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of this study was to determine the progression free survival in patients with metastatic pancreatic cancer and in patients with locally advanced unresectable non-metastatic pancreatic cancer treated with a dose-attenuated modification of folinic acid, fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX). Secondary endpoints included: determine objective response rate according to RECIST; determine overall survival; evaluate toxicity; determine rate of resection in locally advanced unresectable stratum; correlate time to progression, objective response, and overall survival with early changes in glucose metabolism using \[18F\]-fluorodeoxyglucose (FDG)-positron emission tomography (PET) scanning.
Conditions Studied
Interventions
- DRUG Folfirinox
Study Locations (1)
Connecticut
- Smilow Cancer Center - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2011-10 |
| Est. Completion | 2015-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01523457
The ClinicalTrials.gov registry entry for NCT01523457 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (81% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pancreatic Cancer appearing as the primary indexed condition, and to 1 intervention - of which Folfirinox is the first listed.
NCT01523457 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.
Frequently Asked Questions
What is clinical trial NCT01523457 about?
NCT01523457 is a clinical study titled "Study of Modified FOLFIRINOX in Advanced Pancreatic Cancer". The primary objective of this study was to determine the progression free survival in patients with metastatic pancreatic cancer and in patients with locally advanced unresectable non-metastatic pancreatic cancer treated with a dose-attenuated modification of folinic acid, fluorouracil, irinotecan, ...
What is the current status of trial NCT01523457?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2011-10. Estimated completion is 2015-12.
What conditions does trial NCT01523457 study?
This clinical trial studies the following conditions: Pancreatic Cancer, Metastatic Pancreatic Cancer.
What interventions are being tested in trial NCT01523457?
The interventions under investigation include: Folfirinox (DRUG).
Who is sponsoring clinical trial NCT01523457?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01523457 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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