Ignite Creation Date:
2024-05-06 @ 2:13 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT01992705
Status:
COMPLETED
Last Update Posted:
2019-08-19
First Post:
2013-09-27
Brief Title:
Borderline Pancreas Study FOLFIRINOX SBRT
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Neoadjuvant FOLFIRINOX and Stereotactic Body Radiotherapy SBRT Followed by Definitive Surgery for Patients With Borderline Resectable Pancreatic Adenocarcinoma A Single-Arm Pilot Study
Status:
COMPLETED
Status Verified Date:
2019-08
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:
GCC 1324
Brief Summary:
Primary Objective To determine the rate of downstaging to resectability in patients with borderline resectable pancreatic cancer receiving FOLFIRINOX and SBRT as preoperative therapy
Secondary Objectives
1 To assess the disease-free-survival overall survival time to recurrence and site of recurrence in patients with borderline resectable pancreatic cancer receiving preoperative FOLFIRINOX followed by SBRT
2 To investigate the safety and tolerability of FOLFIRINOX and SBRT in patients with resectable pancreatic cancer
3 To determine the radiologic and pathological response associated with preoperative SBRT and FOLFIRINOX therapy
4 To assess quality of life through and after treatment using the FACT-Hep questionnaire
Secondary Objectives
1 To assess the disease-free-survival overall survival time to recurrence and site of recurrence in patients with borderline resectable pancreatic cancer receiving preoperative FOLFIRINOX followed by SBRT
2 To investigate the safety and tolerability of FOLFIRINOX and SBRT in patients with resectable pancreatic cancer
3 To determine the radiologic and pathological response associated with preoperative SBRT and FOLFIRINOX therapy
4 To assess quality of life through and after treatment using the FACT-Hep questionnaire
Detailed Description:
The study investigators hypothesize that neoadjuvant FOLFIRINOX can be safely and efficaciously delivered using a sequential regimen with SBRT as an alternative to standard neoadjuvant chemoradiotherapy Standard of care neoadjuvant treatment typically requires about six weeks of treatment with sub-systemic dosing of chemotherapy The feasibility of the sequential delivery of the FOLFIRINOX followed by SBRT will be evaluated by capturing the prevalence of grade 3 toxicity and the treatment delay rate
In our study SBRT is planned sequentially to follow cycle 4 of chemotherapy treatment provided toxicity has resolved to grade 2 or less Thus allowing for resolution of chemotherapy toxicity prior to initiation of radiation therapy This interval and the fact that there is no concurrent delivery of chemo-RT based on previously discussed experiences including approaches where SBRT safely follows other intense chemotherapy regimens see Polistina et al and Chuong 3536 makes this study feasible without establishing toxicity profile
The proposed regimen of 4 cycles of FOLFIRINOX followed by 30 Gy5 fractions using SBRT will be safely tolerated and will improve resectability rates in borderline resectable PDAC patients In addition this regimen will not compromise the ability to achieve a successful Whipple resection
This regimen will improve the local control rate and overall disease free survival in this patient population The investigators further hypothesize that early administration of FOLFIRNOX will provide optimal systemic therapy to control clinically occult micrometastases
In our study SBRT is planned sequentially to follow cycle 4 of chemotherapy treatment provided toxicity has resolved to grade 2 or less Thus allowing for resolution of chemotherapy toxicity prior to initiation of radiation therapy This interval and the fact that there is no concurrent delivery of chemo-RT based on previously discussed experiences including approaches where SBRT safely follows other intense chemotherapy regimens see Polistina et al and Chuong 3536 makes this study feasible without establishing toxicity profile
The proposed regimen of 4 cycles of FOLFIRINOX followed by 30 Gy5 fractions using SBRT will be safely tolerated and will improve resectability rates in borderline resectable PDAC patients In addition this regimen will not compromise the ability to achieve a successful Whipple resection
This regimen will improve the local control rate and overall disease free survival in this patient population The investigators further hypothesize that early administration of FOLFIRNOX will provide optimal systemic therapy to control clinically occult micrometastases
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