NCT01521702

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2011

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 31, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 20, 2015

Status Verified

March 1, 2015

Enrollment Period

3.2 years

First QC Date

December 22, 2011

Last Update Submit

March 19, 2015

Conditions

Pancreas Cancer

Keywords

adenocarcinomapancreatic head

Outcome Measures

Primary Outcomes (1)

  • progression-free survival

    period from study inclusion until the date of recurrence or surgery (in case of unresectability at surgical exploration).

    from date of randomization until date of progression, assessed up to 5 years

Secondary Outcomes (3)

  • histology

    at 6 months

  • overall survival

    From date of randomization until date of death, assessed up to 5 years

  • complication

    until 6 months

Study Arms (2)

Neoadjuvant chemotherapy

EXPERIMENTAL

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

surgery

ACTIVE COMPARATOR

surgery

Procedure: surgery and Adjuvant chemotherapy

Interventions

Neoadjuvant chemotherapyDRUG

four bi-weekly cycles of gemcitabine (intravenous infusion of 1000mg/m2 over 30 minutes) and oxaliplatin (intravenous infusion of 100mg/m2 over 2 hours,

Neoadjuvant chemotherapy
surgery and Adjuvant chemotherapyPROCEDURE

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.

surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Paoli Calmettes

Marseille, 13009, France

Location

Related Links

MeSH Terms

Conditions

Pancreatic NeoplasmsAdenocarcinoma

Interventions

Neoadjuvant TherapySurgical Procedures, OperativeChemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Jean-Luc RAOUL, MD

    Institut Paoli-Calmettes

    PRINCIPAL INVESTIGATOR

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

December 22, 2011

First Posted

January 31, 2012

Study Start

December 1, 2011

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 20, 2015

Record last verified: 2015-03

Locations

FR(1)