drugset / Trial / NCT03492671

Testing the Combination of Two Approved Chemotherapy Drugs and Radiation Prior to Surgery in Localized Pancreatic Cancer

NCT03492671 ↗

Phase 2 Recruiting 30 enrolled Loma Linda University
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this phase 2 research study is to determine whether a combination of chemotherapy drugs plus radiation therapy, given before surgery in resectable pancreactic cancer, can help to increase the chances of surgeons achieving and R0 resection. The chemotherapy drugs used are gemcitabine and nab-paclitaxel. These drugs are both approved by the FDA for use in treating adults with pancreatic adenocarcinoma. The investigational portion of this study is providing the chemotherapy drugs and radiation therapy before surgery. Primary Endpoint, R) resection rate ≥70%. Secondary Endpoints, Disease free survival, Overall survival , Perioperative mortality and morbidity.

Timeline

Start
2019-07-17
Primary completion
2026-09
Completion
2026-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject Nab-paclitaxel Small molecule 125 mg/m2 Intravenous