RECRUITING

Neoadjuvant Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma

Conditions

Pancreas Adenocarcinoma Borderline Resectable Pancreatic Adenocarcinoma Locally Advanced Pancreatic Adenocarcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The objective of this research is to find out what effects (good and bad), the sequence of Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX, the standard chemotherapy for pancreatic cancer, has on participants and their condition. Gemcitabine - Abraxane (nab-Paclitaxel) and mFOLFIRINOX has been approved by the US Food and Drug Administration (FDA) as first line treatment for advanced pancreatic cancer. The sequence of Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX has not been approved by the FDA for treatment of pancreatic cancer.

Official Title

Sequential Neoadjuvant Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma

Quick Facts

Study Start:2023-08-01

Study Completion:2029-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05825066

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients must have histologically or cytologically proven adenocarcinoma of the pancreas. Patients with mixed tumor with predominant adenocarcinoma pathology can be enrolled * Patients with borderline resectable or locally advanced pancreatic adenocarcinoma as assessed per NCCN guidelines (either pancreatic head, neck, uncinate process, or body/tail) or institutional multidisciplinary consensus * Age 18 or above * Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1 * Patients must have organ and marrow function as defined below: * It is acceptable to transfuse packed red blood cells (PRBC) and platelets at the time of enrollment to meet the eligibility criteria. * If obstructive jaundice is present, then biliary drainage must be initiated and total bilirubin less than or equal to 3.0. * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). * Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative)	* Patients who have had prior chemotherapy with gemcitabine and/or nab-paclitaxel or FOLFIRINOX for pancreatic cancer * Patients receiving any other investigational anti-neoplastic agents * History of malignancy in last 3 years except cervical cancer in situ, adequately treated basal cell or squamous cell carcinoma of skin or treated low risk prostate cancer, who are considered to be eligible * Patients with active and uncontrolled bacterial, viral or fungal infection requiring systemic therapy. Patients can be reevaluated for the study if the infection is deemed to be under control and the systemic therapy for the infection is completed * Uncontrolled intercurrent illness including, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the patient's safety * Patients with known diagnosis of interstitial lung disease, sarcoidosis, pulmonary fibrosis, or pneumonitis requiring oxygen supplementation. Those that do not require oxygen supplementation are eligible. * Patients who have undergone surgery, other than diagnostic or minor procedures, within 4 weeks prior to the initiation of study treatment * Patients who are pregnant or breastfeeding

Inclusion Criteria

Exclusion Criteria

* Patients must have histologically or cytologically proven adenocarcinoma of the pancreas. Patients with mixed tumor with predominant adenocarcinoma pathology can be enrolled
* Patients with borderline resectable or locally advanced pancreatic adenocarcinoma as assessed per NCCN guidelines (either pancreatic head, neck, uncinate process, or body/tail) or institutional multidisciplinary consensus
* Age 18 or above
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
* Patients must have organ and marrow function as defined below:
* It is acceptable to transfuse packed red blood cells (PRBC) and platelets at the time of enrollment to meet the eligibility criteria.
* If obstructive jaundice is present, then biliary drainage must be initiated and total bilirubin less than or equal to 3.0.
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
* Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative)

* Patients who have had prior chemotherapy with gemcitabine and/or nab-paclitaxel or FOLFIRINOX for pancreatic cancer
* Patients receiving any other investigational anti-neoplastic agents
* History of malignancy in last 3 years except cervical cancer in situ, adequately treated basal cell or squamous cell carcinoma of skin or treated low risk prostate cancer, who are considered to be eligible
* Patients with active and uncontrolled bacterial, viral or fungal infection requiring systemic therapy. Patients can be reevaluated for the study if the infection is deemed to be under control and the systemic therapy for the infection is completed
* Uncontrolled intercurrent illness including, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the patient's safety
* Patients with known diagnosis of interstitial lung disease, sarcoidosis, pulmonary fibrosis, or pneumonitis requiring oxygen supplementation. Those that do not require oxygen supplementation are eligible.
* Patients who have undergone surgery, other than diagnostic or minor procedures, within 4 weeks prior to the initiation of study treatment
* Patients who are pregnant or breastfeeding

Contacts and Locations

Study Contact

Study Coordinator

CONTACT

336-713-6912

ahumbert@wakehealth.edu

Principal Investigator

Ravi K Paluri, MD, MPH

PRINCIPAL_INVESTIGATOR

Wake Forest Baptist Comprehensive Cancer Center

Study Locations (Sites)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

Ravi K Paluri, MD, MPH, PRINCIPAL_INVESTIGATOR, Wake Forest Baptist Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-01

Study Completion Date2029-07

Study Record Updates

Study Start Date2023-08-01

Study Completion Date2029-07

Terms related to this study

Additional Relevant MeSH Terms

Pancreas Adenocarcinoma
Borderline Resectable Pancreatic Adenocarcinoma
Locally Advanced Pancreatic Adenocarcinoma