NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer (NEOPAC)
This study is currently recruiting participants.
Verified March 2013 by Institut Paoli-Calmettes
Sponsor:
Institut Paoli-Calmettes
Information provided by (Responsible Party):
Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:
NCT01521702
First received: December 22, 2011
Last updated: March 19, 2013
Last verified: March 2013
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Purpose
The aim of this study is to test the additional value of neoadjuvant chemotherapy to the standard treatment for resectable pancreatic cancer (surgery + adjuvant chemotherapy).
This study will be performed in compliance with the study protocol, GCP (good clinical practice) and the applicable regulatory requirements.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreas Cancer |
Drug: Neoadjuvant chemotherapy Procedure: surgery and Adjuvant chemotherapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Institut Paoli-Calmettes:
Primary Outcome Measures:
- progression-free survival [ Time Frame: from date of randomization until date of progression, assessed up to 5 years ] [ Designated as safety issue: No ]period from study inclusion until the date of recurrence or surgery (in case of unresectability at surgical exploration).
Secondary Outcome Measures:
- histology [ Time Frame: at 6 months ] [ Designated as safety issue: No ]histological response,
- overall survival [ Time Frame: From date of randomization until date of death, assessed up to 5 years ] [ Designated as safety issue: No ]time from date of inclusion to date of death
- complication [ Time Frame: until 6 months ] [ Designated as safety issue: Yes ]complication rates after surgery,
| Estimated Enrollment: | 310 |
| Study Start Date: | December 2011 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Neoadjuvant chemotherapy
After initial staging laparoscopy, Neoadjuvant chemotherapy consists of four bi-weekly cycles of gemcitabine (intravenous infusion of 1000mg/m2 over 30 minutes) and oxaliplatin (intravenous infusion of 100mg/m2 over 2 hours, modified from the Louvet protocol11).
|
Drug: Neoadjuvant chemotherapy
four bi-weekly cycles of gemcitabine (intravenous infusion of 1000mg/m2 over 30 minutes) and oxaliplatin (intravenous infusion of 100mg/m2 over 2 hours,
Other Name: Neoadjuvant chemotherapy
|
|
Active Comparator: surgery
surgery
|
Procedure: surgery and Adjuvant chemotherapy
surgery and Adjuvant chemotherapy must be started within eight weeks after surgery and is based on the standard regimen using six cycles of gemcitabine (Gem 1000mg/m2 over 30 minutes) on days 1, 8, 15 every 4 weeks.
Other Name: surgery and Adjuvant chemotherapy
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 pessars (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01521702
Contacts
| Contact: Dominique GENRE, MD | 33491223778 | bec@marseille.fnclcc.fr |
| Contact: Agnès BOYER CHAMMARD, MD | 33491223778 | bec@marseille.fnclcc.fr |
Locations
| France | |
| Institut Paoli Calmettes | Recruiting |
| Marseille, France, 13009 | |
| Contact: Jean-Luc RAOUL, MD 33491223778 bec@marseille.fnclcc.fr | |
| Principal Investigator: Jean-Luc RAOUL, MD | |
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
| Principal Investigator: | Jean-Luc RAOUL, MD | Institut Paoli-Calmettes |
More Information
Additional Information:
No publications provided
| Responsible Party: | Institut Paoli-Calmettes |
| ClinicalTrials.gov Identifier: | NCT01521702 History of Changes |
| Other Study ID Numbers: | NEOPAC / IPC 2011-002 |
| Study First Received: | December 22, 2011 |
| Last Updated: | March 19, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Institut Paoli-Calmettes:
|
adenocarcinoma pancreatic head |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Adjuvants, Immunologic Gemcitabine Oxaliplatin Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 16, 2013