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

Phase 3
18 Years
Open (Enrolling)
Pancreatic Cancer

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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

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.

Inclusion Criteria

Inclusion criteria:

- resectable adenocarcinoma of the pancreatic head (requiring duodeno-pancreatectomy)

- T1-3, Nx, M0 (UICC 6th version, 2002)

- infiltration of the portal vein (<180°) is not an exclusion criterion

- cytologic or histologic confirmation of adenocarcinoma

- age >18 years

- written informed consent

Exclusion criteria:

- contraindication for Whipple procedure

- an infiltration >180° of the portal vein

- abutment of the tumor to the superior mesenteric artery

- infiltration of the superior mesenteric artery or the celiac trunk

- chronic neuropathy > grade 2

- WHO performance score >2

- uncorrectable cholestasis (bilirubin > 100mmol/l despite drainage attempts for more
than four weeks prior to inclusion)

- female patients in child bearing age not using adequate contraception (oral or
subcutaneous contraceptives, intrauterine pessary (IUP), condoms)

- pregnant or lactating women

- mental or organic disorders which could interfere with giving informed consent or
receiving treatments

- Second malignancy diagnosed within the past 5 years, except non-melanomatous skin
cancer or non-invasive cervical cancer

- percutaneous biopsy of the primary tumor

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Description:

by computed tomography

Outcome Time Frame:

9 months after inclusion

Safety Issue:


Principal Investigator

Pierre-Alain Clavien, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

UniversitaetsSpital Zuerich


Switzerland: Swissmedic

Study ID:




Start Date:

September 2009

Completion Date:

September 2014

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms