Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-01-02 @ 4:54 AM
Study NCT ID:
NCT02481635
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-08
First Post:
2015-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Gemcitabine/Nab-paclitaxel and Radiation Therapy Followed by Surgery in Patients With Advanced Pancreatic Cancer
Sponsor:
University Health Network, Toronto
Organization:
Study Overview
Official Title:
A Phase I/II Study Evaluating the Feasibility and Safety of Neoadjuvant Gemcitabine/Nab-paclitaxel (GA) and Concurrent Gemcitabine and Radiation Therapy Followed By Pancreatic Resection and Major Arterial Resection for Adenocarcinoma of the Pancreas (ARCAP) in Patients With Advanced Disease
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase 1 (the first phase in testing a new drug, to see how safe a new drug or new indication/population ) and phase 2 (the second phase in testing a new drug or new indication/population to see how effective the drug is) study of neoadjuvant (treatment before the main treatment) with gemcitabine and nab-paclitaxel (abraxane) and gemcitabine and radiation therapy before surgery and then gemcitabine and nab-paclitaxel after surgery in patients with pancreatic cancer that has grown to involve one of the major artery branches.
Detailed Description:
Gemcitabine and nab-paclitaxel are chemotherapy drugs that are currently approved by Health Canada for use in combination for the treatment of pancreatic cancer. However, the combination of gemcitabine and nab-paclitaxel as a neoadjuvant treatment prior to gemcitabine and radiation is experimental. Surgery to remove or reconstruct the major artery is also experimental.
Study Oversight
Has Oversight DMC:
True
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?: