Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2026-02-28 @ 8:48 PM
Study NCT ID:
NCT01821612
Status:
COMPLETED
Last Update Posted:
2025-01-13
First Post:
2013-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chemotherapy and Radiation Therapy Before Surgery Followed by Gemcitabine in Treating Patients with Pancreatic Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Study Overview
Official Title:
Neoadjuvant FOLFIRINOX and Chemoradiation Followed by Definitive Surgery and Postoperative Gemcitabine for Patients with Borderline Resectable Pancreatic Adenocarcinoma: an Intergroup Single-Arm Pilot Study
Status:
COMPLETED
Status Verified Date:
2025-01
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 pilot clinical trial studies combination chemotherapy and radiation therapy before surgery followed by gemcitabine hydrochloride in treating patients with pancreatic cancer. Drugs used in chemotherapy, such as oxaliplatin, irinotecan hydrochloride, leucovorin calcium, fluorouracil, and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.
Detailed Description:
The purpose of this study is to evaluate a new treatment program for patients with borderline resectable pancreas cancer in order to determine what effects, good and bad, chemotherapy and chemoradiation have on your cancer and to see if it allows safe surgery.
Primary Objectives:
* To assess the accrual rate of this study.
* To assess the rate of treatment-related toxicity and treatment delay during preoperative therapy.
* To assess the rate of completion of all preoperative and operative therapy.
Secondary Objectives:
* To assess the macroscopic (R0/R1) resection rate.
* To estimate the rate of radiographic and histopathologic response to preoperative therapy.
* To estimate the time to locoregional and distant recurrence.
* To assess overall survival (OS).
* To retrieve nucleic acids from pretreatment pancreatic ductal adenocarcinoma biopsies and to assess the quality of these nucleic acids using a sequencing-based assessment of tumor DNA.
Primary Objectives:
* To assess the accrual rate of this study.
* To assess the rate of treatment-related toxicity and treatment delay during preoperative therapy.
* To assess the rate of completion of all preoperative and operative therapy.
Secondary Objectives:
* To assess the macroscopic (R0/R1) resection rate.
* To estimate the rate of radiographic and histopathologic response to preoperative therapy.
* To estimate the time to locoregional and distant recurrence.
* To assess overall survival (OS).
* To retrieve nucleic acids from pretreatment pancreatic ductal adenocarcinoma biopsies and to assess the quality of these nucleic acids using a sequencing-based assessment of tumor DNA.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U10CA031946 | NIH | None | https://reporter.nih.gov/quic… | View |