Adjuvant Versus Neoadjuvant Plus Adjuvant Chemotherapy in Resectable Pancreatic Cancer
Status:
Terminated
Trial end date:
2019-05-01
Target enrollment:
Participant gender:
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