Regional Versus Systemic Chemotherapy In The Treatment Of Unresectable Pancreatic Cancer

Study Overview

Regional Versus Systemic Chemotherapy in the Treatment of Unresectable Pancreatic Cancer

Systemic chemotherapy with cytotoxic drug is of limited effectiveness in advanced pancreatic cancer patients. Gemcitabine has been used as the first-line drug for advance pancreatic cancer for over two decades and combinations of gemcitabine with different chemotherapeutic drugs have been investigated to improve the outcomes of pancreatic cancer. However, no substantial improvement in patient survival has been achieved. Locoregional chemotherapy via intra-arterial perfusion or chemoemoblization takes advantage of the increasing local drug concentrations and reducing systemic toxicities. In this study, the investigators hypothesis that artery infusion chemotherapy had a better antitumor effect than systemic chemotherapy. The investigators will analyze and evaluate the effect and safety of an implanted percutaneous left subclavian artery port-catheter drug delivery system for regional chemotherapy of inoperable pancreatic carcinoma.

N/A

Unresectable Pancreatic Cancer

PROCEDURE: regional interventional chemotherapy group

XHDD 003

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 2012-07-15	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2012-08-10
First Submitted that Met QC Criteria 2012-08-10	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2012-08-15
First Posted (ESTIMATED) 2012-08-15	Results First Posted N/A	Last Verified 2012-08

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:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: regional interventional chemotherapy group	PROCEDURE: regional interventional chemotherapy group The patients in experimental group were monitored by X-ray imaging. A 0.038 super-sliding guide wire was inserted after successful puncture, and when site of the pancreatic carcinoma was reconfirmed by conventional angiography, a 5F cobra catheter was use
NO_INTERVENTION: systemic chemotherapy

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: regional interventional chemotherapy group

PROCEDURE: regional interventional chemotherapy group

The patients in experimental group were monitored by X-ray imaging. A 0.038 super-sliding guide wire was inserted after successful puncture, and when site of the pancreatic carcinoma was reconfirmed by conventional angiography, a 5F cobra catheter was use

NO_INTERVENTION: systemic chemotherapy

Primary Outcome Measures	Measure Description	Time Frame
overall surviva		36 months

Secondary Outcome Measures	Measure Description	Time Frame
Clinical Benefit Rate		12 months
The median progression-free survival PFS		12 months
Drug Toxicity	The grading standards of the World Health Organization for acute and subacute toxicity of anticancer drugs will be used to grade toxicity.	18 months
surgical complications	Major surgical complications included allergic reaction to the contrast agent, local hematoma, pneumothorax, puncture site bleeding, wound infection, delayed healing or cracking, port-catheter blockage, and necrosis of the tissue surrounding the port-catheter.	18 months

Contacts and Locations

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

Study Contact

Name: Jun Tie, PH.D., MD

Phone Number: +86-29-84771528

Email: tiejun7776@163.com

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:

Signed written informed consent
Karnofsky score > 60,
Expected survival > 3 months,
Liver, kidney function and routine blood test within normal range
No serious cardiopulmonary dysfunction
No acute infection

Pregnant or lactating women
Uncontrolled internal diseases
Past or the presence of other malignancy
Those who had received immunosuppressive therapy

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Guohong Han, MD, Xijing Hospital of Digestive Diseases, Fourth Military Medical University

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

Han GH, Yin ZX, Meng XJ, He CY, Zhang HB, Sun AH, Wu KC, Ding J, Fan DM. Prospective randomized clinical trial of two drug delivery pathway in the treatment of inoperable advanced pancreatic carcinoma. Chin J Dig Dis. 2006;7(1):45-8. doi: 10.1111/j.1443-9573.2006.00243.x.

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