Regional Versus Systemic Chemotherapy in the Treatment of Unresectable Pancreatic Cancer

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2012 by Fourth Military Medical University
Sponsor:
Information provided by (Responsible Party):
Guohong Han, Fourth Military Medical University
ClinicalTrials.gov Identifier:
NCT01665625
First received: July 15, 2012
Last updated: August 10, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Unresectable Pancreatic Cancer
Procedure: regional interventional chemotherapy group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial of Regional Versus Systemic Continuous Gemcitabine Chemotherapy in the Treatment of Unresectable Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Fourth Military Medical University:

Primary Outcome Measures:
  • overall surviva [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Benefit Rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The median progression-free survival PFS [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Drug Toxicity [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    The grading standards of the World Health Organization for acute and subacute toxicity of anticancer drugs will be used to grade toxicity.

  • surgical complications [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 90
Study Start Date: August 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665625

Contacts
Contact: Jun Tie, PH.D., MD +86-29-84771528 tiejun7776@163.com

Locations
China, Shaanxi
Xijing Hospital of Digestive Diseases, Fourth Military Medical University Not yet recruiting
Xi'an, Shaanxi, China, 710032
Contact: GuoHong Han, MD    86-29-84775221    hangh@fmmu.edu.cn   
Sub-Investigator: Jun Tie, PH.D.,MD         
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Xi`an, Shaanxi, China, 710032
Sponsors and Collaborators
Fourth Military Medical University
Investigators
Principal Investigator: Guohong Han, MD Xijing Hospital of Digestive Diseases, Fourth Military Medical University
  More Information

Publications:
Responsible Party: Guohong Han, Head of Department of Digestive Interventional Radiology, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT01665625     History of Changes
Other Study ID Numbers: XHDD 003
Study First Received: July 15, 2012
Last Updated: August 10, 2012
Health Authority: China: Ethics Committee

Keywords provided by Fourth Military Medical University:
Pancreatic cancer
Intra-arterial infusion
Gemcitabine

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases

ClinicalTrials.gov processed this record on October 20, 2014