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Adjuvant Gemcitabine Versus NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer: a Randomized Multicenter Phase III Study


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Pancreas Cancer

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Trial Information

Adjuvant Gemcitabine Versus NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer: a Randomized Multicenter Phase III Study


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression-free survival

Outcome Description:

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

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Jean-Luc RAOUL, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Paoli-Calmettes

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

NEOPAC / IPC 2011-002

NCT ID:

NCT01521702

Start Date:

December 2011

Completion Date:

Related Keywords:

  • Pancreas Cancer
  • adenocarcinoma
  • pancreatic head
  • Pancreatic Neoplasms

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