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Perioperative Therapy for Resectable and Borderline-Resectable Pancreatic Adenocarcinoma With Molecular Correlates | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Perioperative Therapy for Resectable and Borderline-Resectable Pancreatic Adenocarcinoma With Molecular Correlates

Perioperative Therapy for Resectable Pancreatic Adenocarcinoma and Borderline Resectable Pancreatic Adenocarcinoma With Molecular Correlates

NCT02723331•Academic Thoracic Oncology Medical Investigators Consortium

View on ClinicalTrials.gov

Summary

The objective of this study is to estimate the R0 resection rate in patients with Resectable Pancreatic Ductal Adenocarcinoma (R-PDAC) as well as those with Resectable Pancreatic Ductal Adenocarcinoma (BR-PDAC) independently in response to neoadjuvant sequential therapy of combination nab-paclitaxel and gemcitabine followed by stereotactic body radiotherapy (SBRT).

Detailed Description

Patients in both cohorts will receive a total of 3 cycles of neoadjuvant combination chemotherapy of nab-paclitaxel and gemcitabine, followed by re-staging CT scan, if re-staging CT does not show evidence of metastatic disease. Patients will receive SBRT and definitive surgical resection. Subsequently, patients will receive 3 cycles of adjuvant combination chemotherapy of nab-paclitaxel and gemcitabine. Each cycle of combination chemotherapy will be a total of 4 weeks. Patients will be evaluated for response at completion of the 3 cycles of neoadjuvant combination chemotherapy with CT scans of chest, abdomen and pelvis. Patients will undergo surveillance CT scan at 3-month intervals until evidence of disease progression.

Eligibility

Age

18 - 101 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histologically confirmed resectable or borderline resectable pancreatic adenocarcinoma.
•2. No evidence of distant metastasis representing stage IV metastatic disease.
•3. R-PDAC: No evidence of distant metastasis and tumor mass showing no extension to superior mesenteric artery (SMA) and hepatic artery. There must be a clearly defined fat plane between SMA and celiac axis. Patent superior mesenteric vein (SMV/portal vein (PV) with no distortion of venous architecture.
•4. BR-PDAC: defined as localized PDAC with 1 or more of the following features: a) an interface between the primary tumor and superior mesenteric vein (SMV)-portal vein (PV) measuring 180o or greater of the circumference of the vein wall, and/or b) short-segment occlusion of the SMV-PV with normal vein above and below the level of obstruction that is amenable to resection and venous reconstruction and/or c) short-segment interface of any degree between tumor and hepatic artery with normal artery proximal and distal to the interface that is amenable to resection and arterial reconstruction and/or d) an interface between the tumor and SMA or celiac trunk measuring less than 180o of the circumference of the artery wall.
•5. Age \> 18 years old
•6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•7. Patients must have adequate bone marrow function:
•* Platelets \>100,000 cells/mm3
•* Hemoglobin \> 9.0 g/dL
•* Absolute Neutrophil Count \> 1,500 cells/mm3
+9 more criteria

Exclusion Criteria

•1. Patients with locally advanced surgically unresectable PDAC.
•2. Patients with evidence of distant metastatic PDAC.
•3. Prior chemotherapy or radiation therapy of any kind for treatment of pancreas adenocarcinoma.
•4. Prior major surgery within 4 weeks of starting study drug administration.
•5. Patient unable or not willing to perform all study related biopsies and blood draws for exploratory endpoints will not be enrolled on study as all study related procedures are mandatory.
•6. Concomitant treatment with full dose warfarin (coumadin) is NOT allowed. However, treatment with low molecular weight heparin (LMWH) (such as enoxaparin or dalteparin) or rivaroxaban is allowed. Patients on full dose warfarin (coumadin) must be transitioned to either LMWH or rivaroxaban prior to administration of any study related drugs.
•7. Recent or ongoing clinically significant gastrointestinal disorder (e.g., malabsorption, bleeding, inflammation, emesis, diarrhea \>grade 1).
•8. Patients with clinically significant cardiac disease (New York Heart Association Classification III or IV and cardiac arrhythmias not well controlled with medication), or myocardial infarction within the previous six months.
•9. Serious, uncontrolled, concurrent infection(s) requiring antibiotics.
•10. Pregnant or breastfeeding women: positive pregnancy test within 7 days of starting treatment.
+3 more criteria

Locations (4)

Mayo Clinic Hospital

Scottsdale, Arizona, United States

University of Arizona

Tucson, Arizona, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

New York University

New York, New York, United States

Key Dates

Start Date

December 30, 2016

Primary Completion Date

December 8, 2022

Completion Date

December 28, 2022

Last Updated

July 1, 2025

Enrollment

ACTUAL participants

Conditions

Pancreatic CancerPancreatic AdenocarcinomaPancreas Ductal Adenocarcinoma

Interventions

Nab paclitaxel

DRUG

Gemcitabine

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Perioperative Therapy for Resectable and Borderline-Resectable Pancreatic Adenocarcinoma With Molecular Correlates

Inclusion Criteria

Exclusion Criteria

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