Adjuvant Versus Neoadjuvant Plus Adjuvant Chemotherapy in Resectable Pancreatic Cancer

NCT01314027 | Terminated Phase 3 DMC

• 1 other identifier: NEOPAC
• Study Type: interventional
• Target: 38
• Locations: 4 countries
• Sites: 5

Brief 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

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  by computed tomography

  9 months after inclusion

Secondary Outcomes (5)

• Progression-free survival

  12, 15, 21, 27, 33, 39, ... months after inclusion

• histological response

  Pancreatic resection

• overall survival

  1, 3 and 5 years after inclusion

• complication rates after surgery

  60 days postoperative

• feasibility of adjuvant chemotherapy

  within 8 postoperative weeks

Study Arms (2)

neoadjuvant + adjuvant chemotherapy

EXPERIMENTAL

neoadjuvant chemotherapy is based on gemcitabine/oxaliplatin adjuvant therapy is based on gemcitabine

Drug: Neoadjuvant Chemotherapy with gemcitabine/oxaliplatin

adjuvant chemotherapy

ACTIVE COMPARATOR

adjuvant therapy is based on gemcitabine

Drug: adjuvant chemotherapy with gemcitabine

Interventions

Neoadjuvant Chemotherapy with gemcitabine/oxaliplatin DRUG

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.

Also known as: gemcitabine, eloxatin

neoadjuvant + adjuvant chemotherapy

adjuvant chemotherapy with gemcitabine DRUG

Patients randomized to arm B undergo surgery and receive the same adjuvant treatment as in arm A.

adjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• resectable adenocarcinoma of the pancreatic head (requiring duodeno-pancreatectomy)
• T1-3, Nx, M0 (UICC 6th version, 2002)
• cytologic or histologic confirmation of adenocarcinoma
• age \>18 years
• written informed consent

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (5)

University Hospital of Gent

Ghent, Belgium

Location

University Hospital of Marseille

Marseille, France

Location

University Hospital of Strasbourg

Strasbourg, France

Location

University Hospital Mainz

Mainz, 55131, Germany

Location

University Hospital of Zurich

Zurich, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 21831266 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Neoadjuvant Therapy; Gemcitabine; Oxaliplatin; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Drug Therapy

Study Officials

• Pierre-Alain Clavien, MD, PhD

  UniversitaetsSpital Zuerich

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2010
• First Posted: March 14, 2011
• Study Start: September 1, 2009
• Primary Completion: December 1, 2018
• Study Completion: May 1, 2019
• Last Updated: July 25, 2019

Record last verified: 2019-07

Locations

BE (1); FR (2); CH (1); DE (1)