Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00463840
Status:
TERMINATED
Last Update Posted:
2017-12-05
First Post:
2007-04-18
Brief Title:
Chemoradiation With Oxaliplatin and Fluorouracil 5FU for Locally Advanced Pancreatic Cancer
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
A Phase III Study of Chemoradiation With Oxaliplatin and 5FU for Locally Advanced Pancreatic Cancer
Status:
TERMINATED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The intention of this trial is to determine the maximum tolerated of the treatment combination and to evaluate its safety and efficacy
Detailed Description:
Previous studies have demonstrated that neoadjuvant chemoradiation can lead to improved survival with a portion of patients proceeding to resection This trial will incorporate a similar trial structure using newer agents in patients who present with locally advanced unresectable pancreatic cancer Specifically oxaliplatin will be used owing to its greater activity in comparison to cisplatin and favorable therapeutic index in combination with radiation compared to gemcitabine
In summary the primary outcome measure of the phase I portion of the trial is to determine the maximum tolerated dose of this combination Following the determination of this dose the phase II portion of the trial will characterize the toxicity of this regimen as well as evaluate for long-term efficacy
In summary the primary outcome measure of the phase I portion of the trial is to determine the maximum tolerated dose of this combination Following the determination of this dose the phase II portion of the trial will characterize the toxicity of this regimen as well as evaluate for long-term efficacy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Sanofi-Aventis 0x 03-030 | OTHER | Sanofi-Aventis | None |
| H11640 | OTHER | None | None |