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

Phase 2 Completed 48 enrolled Academic Thoracic Oncology Medical Investigators Consortium Celgene Corporation · collab Criterium, Inc. · collab University of Colorado, Denver · collab

Non-randomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start: 2016-12-30
Primary completion: 2022-12-08
Completion: 2022-12-28

Outcome

Mixed primary results

paper the trial failed to meet one of its primary objectives PMID 40972532 ↗

paper the objective of 30% R0 resection for the BR-PDAC group was met PMID 40972532 ↗

Publications

Cohen DJ, Goldberg JD, Leichman L, Hochman T, Newman E, Du K, Megibow A, Oberstein P, Al-Rajabi R, Scott AJ, Bekaii-Saab T, Messersmith WA, Weekes C. Perioperative therapy for resectable and borderline resectable pancreatic adenocarcinoma: an Academic Gastrointestinal Cancer Consortium Study. Oncologist. 2025 Oct 1;30(10):oyaf271. doi: 10.1093/oncolo/oyaf271.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Subject	Nab-paclitaxel	Small molecule	125 mg/m2	Intravenous