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

Lilly

Status and phase: Completed; Phase 2

Conditions: Pancreatic Neoplasms

Treatments: Procedure: Radiotherapy; Drug: Gemcitabine; Drug: Oxaliplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00191568

6866

B9E-MC-S298

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)