Gemcitabine, Oxaliplatin and Radiotherapy in Treating Patients With Completely Resected Pancreatic Cancer

Phase 2CompletedNCT00191568

Eli Lilly and Company45 enrolled

Overview

A non-randomized phase II study to determine the efficacy and safety of the combination of Gemcitabine and Oxaliplatin followed by Gemcitabine and radiotherapy in patients with surgically resected pancreatic cancer.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Neoplasms

Interventions

GemcitabineDRUG

OxaliplatinDRUG

RadiotherapyPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pathologically confirmed adenocarcinoma of the pancreas * Patient have undergone a potentially curative resection * No previous irradiation to the planned field * Negative pregnancy test for child bearing women Exclusion Criteria: * Non-adenocarcinoma pancreatic cancer * Treatment with any drug within the last 30 days that has not received regulatory approval. * Serious systemic disorder * Metastatic disease * Pregnancy, breast feeding

Locations (6)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) MON-FRI 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician

Grenoble, France

Lyon, France

Outcomes

Primary Outcomes

To evaluate recurrence free one year survival, time to disease progression and local recurrence rate, analyzed at the end of the study

Secondary Outcomes

To assess overall survival at the end of the 24 months follow up period;To assess acute and late toxicity (every month for the first 3 months and then every three months for 24 months after treatment discontinuation)

Data from ClinicalTrials.gov

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