Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2026-02-27 @ 1:09 AM
Study NCT ID:
NCT03322995
Status:
RECRUITING
Last Update Posted:
2024-11-21
First Post:
2017-10-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pancreatic Cancer Adaptive Neoadjuvant Chemotherapy Trial
Sponsor:
Medical College of Wisconsin
Organization:
Study Overview
Official Title:
Adaptive Modification of Neoadjuvant Therapy Based on Clinical Response in Patients With Localized Pancreatic Cancer
Status:
RECRUITING
Status Verified Date:
2024-11
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:
PANC
Brief Summary:
This is an open-label, phase II study in patients with resectable and borderline resectable pancreas cancer.
Detailed Description:
Patients will receive standard chemotherapy and chemoradiation for pancreatic cancer. The study intervention is an adaptive approach which modifies systemic therapy based on clinical assessments of treatment response. Treatment response will be assessed by imaging (CT scan), biomarker \[serum cancer antigen (CA)19-9\] and performance status assessment \[short physical performance battery (SPPB) and Center for Epidemiologic Studies Depression Scale (CES-D) evaluations\] at the first restaging assessment.
Treatment response will be categorized as:
1. response;
2. stable disease;
3. local disease progression;
4. metastatic disease progression.
After the first restaging evaluation, patients who demonstrate:
1. a response will be maintained on the same chemotherapy;
2. stable disease will be changed to a defined alternative chemotherapy or molecular profile-directed therapy;
3. local progression will receive chemoradiation;
4. metastatic disease will be removed from the trial.
Patients who complete four months of chemotherapy, will be treated with chemoradiation (50.4 Gray (Gy) in 28 fractions). In the absence of local disease progression deemed inoperable, or metastatic disease progression, patients will be offered surgical resection. Patients who did not receive four months of systemic therapy in the neoadjuvant setting will be offered four months of adjuvant therapy at the discretion of their treating physicians.
Treatment response will be categorized as:
1. response;
2. stable disease;
3. local disease progression;
4. metastatic disease progression.
After the first restaging evaluation, patients who demonstrate:
1. a response will be maintained on the same chemotherapy;
2. stable disease will be changed to a defined alternative chemotherapy or molecular profile-directed therapy;
3. local progression will receive chemoradiation;
4. metastatic disease will be removed from the trial.
Patients who complete four months of chemotherapy, will be treated with chemoradiation (50.4 Gray (Gy) in 28 fractions). In the absence of local disease progression deemed inoperable, or metastatic disease progression, patients will be offered surgical resection. Patients who did not receive four months of systemic therapy in the neoadjuvant setting will be offered four months of adjuvant therapy at the discretion of their treating physicians.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: