Regional Versus Systemic Chemotherapy in the Treatment of Unresectable Pancreatic Cancer

August 10, 2012 updated by: Guohong Han, Air Force Military Medical University, China

A Prospective Randomized Trial of Regional Versus Systemic Continuous Gemcitabine 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

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

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital of Digestive Diseases, Fourth Military Medical University
        • Contact:
        • Sub-Investigator:
          • Jun Tie, PH.D.,MD

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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 used to place the port-catheter drug delivery system in the celiac artery (pancreatic head) or the hepatic artery (pancreatic body and tail). Finally, the port-catheter was embedded under the left upper chest.
No Intervention: systemic chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall surviva
Time Frame: 36 months
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Benefit Rate
Time Frame: 12 months
12 months
The median progression-free survival PFS
Time Frame: 12 months
12 months
Drug Toxicity
Time Frame: 18 months
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
Time Frame: 18 months
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

Collaborators and Investigators

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

Sponsor

Air Force Military Medical University, China

Investigators

  • Principal Investigator: Guohong Han, MD, Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Publications and helpful links

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

General Publications

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 Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

July 15, 2012

First Submitted That Met QC Criteria

August 10, 2012

First Posted (Estimate)

August 15, 2012

Study Record Updates

Last Update Posted (Estimate)

August 15, 2012

Last Update Submitted That Met QC Criteria

August 10, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XHDD 003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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