NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer (NEOPAC)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified October 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: October 30, 2013
Last verified: October 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
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 ClinicalTrials.gov identifier: NCT01521702
Please refer to this study by its ClinicalTrials.gov identifier: NCT01521702
Contacts
| Contact: Dominique GENRE, MD | 33491223778 | drci.up@ipc.unicancer.fr | |
| Contact: Agnès BOYER CHAMMARD, MD | 33491223778 | drci.up@ipc.unicancer.fr |
Locations
| France | |
| Institut Paoli Calmettes | Recruiting |
| Marseille, France, 13009 | |
| Contact: Jean-Luc RAOUL, MD 33491223778 drci.up@ipc.unicancer.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: | October 30, 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:
|
Gemcitabine Oxaliplatin Anti-Infective Agents Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Antiviral Agents Enzyme Inhibitors |
Immunologic Factors Immunosuppressive Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Radiation-Sensitizing Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015