A Phase II Pilot Study to Evaluate the Efficacy and Safety of Neoadjuvant Chemoradiotherapy With Capecitabine, Panitumumab and External Beam Radiation, in Patients With Localized, Non-Metastatic Pancreatic Adenocarcinoma
Surgical resection remains the standard procedure for patients with localized resectable
Neoadjuvant or preoperative therapy with chemotherapy and radiation therapy has been
proposed as an alternative approach in patients with localized pancreatic adenocarcinoma.
Advantages are: 1) early start of systemic therapy targeting micrometastatic disease; 2)
increased compliance with chemoradiotherapy; 3) increase primary tumor complete resection
rates; 4) avoidance of surgery in patients with rapidly developing metastatic disease; and
5) importantly, it provides an important resource for research in terms of tissue
acquisition before and after therapy . Finally, this is an opportunity to test the safety
and efficacy of a novel combination of weekly panitumumab, oral capecitabine and radiation
in pancreatic cancer.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To estimate the 3 year progression-free survival of patients with localized, resectable pancreatic cancer
To estimate the proportions of patients (with localized, resectable and borderline resectable, non-metastatic pancreatic adenocarcinoma) treated with the study regimen alive at 2-years from the date of registration.
Bilal Piperdi, MD
University of Massachusetts, Worcester
United States: Institutional Review Board
|University of Massachusetts Medical School||Worcester, Massachusetts 01605|