Phase Ⅱ Trial of Fixed Dose Rate Gemcitabine and Cisplatin Chemotherapy Followed by Chemoradiation With Capecitabine in Patients With Locally Advanced Pancreatic Cancer

Seoul National University Hospital2 sites in 1 country35 target enrollmentDecember 2004

ConditionsPancreatic Cancer

Drugsgemcitabine, cisplatin, capecitabine

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Pancreatic Cancer
Sponsor: Seoul National University Hospital
Enrollment: 35
Locations: 2
Primary Endpoint: Time to progression
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase Ⅱ trial of fixed dose rate gemcitabine and cisplatin chemotherapy followed by chemoradiation with capecitabine in patients with locally advanced pancreatic cancer.

Detailed Description

The main purpose of this study is to evaluate the efficacy and safety of fixed dose rate gemcitabine and cisplatin chemotherapy followed by chemoradiation with capecitabine in patients with locally advanced pancreatic cancer.

Registry

clinicaltrials.gov

Start Date

December 2004

End Date

June 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

•unresectable locally advanced pancreatic cancer
•no distant metastasis
•histologically confirmed adenocarcinoma of pancreas
•18-75 of age
•ECOG performance status 0-2
•normal marrow function :
•WBC at least 3,000/mm3 OR Absolute neutrophil count at least 1,500/mm3
•Platelet count at least 100,000/mm3
•normal liver function :
•-Bilirubin no greater than 2.0 mg/dL AST less than 3 times upper limit of normal (ULN)