Trial Information

Adjuvant Gemcitabine Versus NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer: a Randomized Multicenter Phase III Study (NEOPAC Study)

Due to the improvement in the recurrence-free and overall survival by adjuvant chemotherapy,
surgery followed by adjuvant chemotherapy is currently considered the standard treatment for
resectable pancreatic cancer. However, a significant proportion (>25%) of patients cannot
receive adjuvant treatment due to the morbidity of pancreas surgery. Neoadjuvant
(preoperative) chemotherapy appears particularly attractive since it can be applied to all
patients and has resulted in a significant histological tumor response with a median
survival superior to adjuvant chemotherapy in a recent prospective phase II trial.

The aim of this study is to determine the role of neoadjuvant chemotherapy in patients with
resectable pancreatic cancer.Eligible patients are randomized to:

arm A: neoadjuvant chemotherapy + resection + adjuvant chemotherapy arm B: resection +
adjuvant chemotherapy Neoadjuvant chemotherapy consists of gemcitabine (1000mg/m2) and
oxaliplatin (100mg/m2) on days 1, 15, 29 and 43, while adjuvant chemotherapy is based on
gemcitabine 1000mg/m2 for 6 months.

If the restaging protocol excludes distant metastases, a diagnostic laparoscopy is
performed, followed by a Whipple operation in the absence of distant metastases.

The primary study end-point is the recurrence-free survival after study inclusion, and this
is defined by the interval between the date of written informed consent until recurrence.
Secondary end-points are the overall survival and the surgical complication rate. Interim
analyses are performed after the inclusion of 100 and 200 patients without interrupting
patient accrual. An independent data monitoring committee will review the results of each
interim analysis and will decide about the study cessation or continuation.

Patients will be followed-up according to the protocol below in order to assess tumor
recurrence.

Quality of life will be assessed by the QLQ-30 questionnaire of the EORTC at study entry,
after neoadjuvant chemotherapy, start and end of the adjuvant chemotherapy and at each
follow-up study visit. Representative histological samples are reviewed and stored by the
reference pathologist at the University Hospital of Zurich. These samples will also be used
to determine the histological response and extent of cytopathic effects. Furthermore, the
nutritional status is assessed from all patients by the prealbumin serum levels at study
entry and prior to surgery. Further translational research is desired and will be
individually organized by each center.