Fixed Dose Rate Gemcitabine And Cisplatin Followed By Chemoradiation For Locally Advanced Pancreatic Cancer

Study Overview

Fixed Dose Rate Gemcitabine and Cisplatin Followed by Chemoradiation for Locally Advanced Pancreatic Cancer

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.

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.

Pancreatic Cancer

DRUG: gemcitabine, cisplatin, capecitabine

H-0412-138-005

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2011-07-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2011-07-15
First Submitted that Met QC Criteria 2011-07-15	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2011-07-19
First Posted (ESTIMATED) 2011-07-19	Results First Posted N/A	Last Verified 2011-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Time to progression		12 months

Secondary Outcome Measures	Measure Description	Time Frame
safety	number of patients who experienced grade 3-4 toxicity by NCI-CTCAE	12 months
1 year survival rate		1 year
response rate	response rate by RECIST criteria	1 year
overall survival		1 year
clinical benefit rate	CR+PR+SD by RECIST criteria	1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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 :

normal renal function :

signed informed consent

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Seock-Ah Im, MD, PhD, Seoul National University Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record