Adjuvant Versus Neoadjuvant Plus Adjuvant Chemotherapy in Resectable Pancreatic Cancer

Summary

The outcome of patients with resected pancreatic cancer has significantly been improved by adjuvant chemotherapy. However, a large proportion of patients cannot receive adjuvant chemotherapy due to surgical complications. Neoadjuvant chemotherapy has been shown to be safe and effective and can be applied to all patients. This study should test neoadjuvant chemotherapy in a randomized manner. Patients with resectable cytologically proven adenocarinoma of the pancreatic head are randomized to arm A or B. Patients randomized to arm A receive an 8-week neoadjuvant chemotherapy with gemcitabine/oxaliplatin followed by surgery. Thereafter, all patients receive adjuvant gemcitabine for six months. Patients randomized to arm B undergo surgery and receive the same adjuvant treatment as in arm A. The primary study-endpoint is the recurrence-free survival. Tumor recurrence are determined by computed tomography in a defined protocol. * Trial with medicinal product

Timeline

Start

2009-09

Primary completion

2018-12

Completion

2019-05

Outcome

Outcome not reported

Stopped (Enrollment): “low recruitment”

Publications

• Heinrich S, Pestalozzi B, Lesurtel M, Berrevoet F, Laurent S, Delpero JR, Raoul JL, Bachellier P, Dufour P, Moehler M, Weber A, Lang H, Rogiers X, Clavien PA. Adjuvant gemcitabine versus NEOadjuvant gemcitabine/oxaliplatin plus adjuvant gemcitabine in resectable pancreatic cancer: a randomized multicenter phase III study (NEOPAC study). BMC Cancer. 2011 Aug 10;11:346. doi: 10.1186/1471-2407-11-346.

Drugs

Indications