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Adjuvant Versus Neoadjuvant Plus Adjuvant Chemotherapy in Resectable Pancreatic Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by University of Zurich.
Recruitment status was:  Recruiting
Information provided by:
University of Zurich Identifier:
First received: September 29, 2010
Last updated: March 10, 2011
Last verified: March 2011

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

Condition Intervention Phase
Pancreatic Cancer Drug: Neoadjuvant Chemotherapy with gemcitabine/oxaliplatin Drug: adjuvant chemotherapy with gemcitabine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adjuvant Gemcitabine Versus NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer: a Randomized Multicenter Phase III Study (NEOPAC Study)

Resource links provided by NLM:

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 9 months after inclusion ]
    by computed tomography

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 12, 15, 21, 27, 33, 39, ... months after inclusion ]
    by computer tomography

  • histological response [ Time Frame: Pancreatic resection ]

  • overall survival [ Time Frame: 1, 3 and 5 years after inclusion ]
  • complication rates after surgery [ Time Frame: 60 days postoperative ]
  • feasibility of adjuvant chemotherapy [ Time Frame: within 8 postoperative weeks ]

Estimated Enrollment: 310
Study Start Date: September 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: neoadjuvant + adjuvant chemotherapy
neoadjuvant chemotherapy is based on gemcitabine/oxaliplatin adjuvant therapy is based on gemcitabine
Drug: Neoadjuvant Chemotherapy with gemcitabine/oxaliplatin

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. Thereafter, surgery is performed if the restaging does not reveal a contraindication. Finally, all patients receive adjuvant gemcitabine for six months.

Other Names:
  • gemcitabine
  • eloxatin
Active Comparator: adjuvant chemotherapy
adjuvant therapy is based on gemcitabine
Drug: adjuvant chemotherapy with gemcitabine
Patients randomized to arm B undergo surgery and receive the same adjuvant treatment as in arm A.

Detailed Description:

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01314027

Contact: Pierre-Alain Clavien, MD, PhD +41 44 255 3300

University Hospital of Gent Not yet recruiting
Gent, Belgium
Contact: Frederick Berrevoet, MD         
University Hospital of Marseille Not yet recruiting
Marseille, France
Contact: Jean-Robert Delpero, MD         
University Hospital of Strasbourg Not yet recruiting
Strasbourg, France
Contact: Philippe Bachellier, MD         
University Hospital Mainz Not yet recruiting
Mainz, Germany, 55131
Contact: Stefan Heinrich, MD    0049 6131 17 2738   
Sub-Investigator: Stefan Heinrich, MD         
University Hospital of Zurich Recruiting
Zurich, Switzerland
Contact: Pierre-Alain Clavien, MD, PhD    0041 44 255 3300   
Sub-Investigator: Mickael Lesurtel, MD         
Sub-Investigator: Bernhard Pestalozzi, MD         
Sub-Investigator: Stefan Heinrich, MD         
Sponsors and Collaborators
University of Zurich
Study Director: Pierre-Alain Clavien, MD, PhD UniversitaetsSpital Zuerich
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Clavien Pierre-Alain, Prof. Dr., VIS Klinik f. Viszeralchirurgie Identifier: NCT01314027     History of Changes
Other Study ID Numbers: NEOPAC
Study First Received: September 29, 2010
Last Updated: March 10, 2011

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on September 21, 2017