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Trial Title:
Regional Versus Systemic Chemotherapy in the Treatment of Unresectable Pancreatic Cancer
NCT ID:
NCT01665625
Condition:
Unresectable Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Conditions: Keywords:
Pancreatic cancer
Intra-arterial infusion
Gemcitabine
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
regional interventional chemotherapy group
Description:
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.
Arm group label:
regional interventional chemotherapy group
Summary:
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Address:
City:
Xi'an
Zip:
710032
Country:
China
Facility:
Name:
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Address:
City:
Xi'an
Zip:
710032
Country:
China
Contact:
Last name:
GuoHong Han, MD
Phone:
86-29-84775221
Email:
hangh@fmmu.edu.cn
Investigator:
Last name:
Jun Tie, PH.D.,MD
Email:
Sub-Investigator
Start date:
August 2012
Completion date:
February 2016
Lead sponsor:
Agency:
Air Force Military Medical University, China
Agency class:
Other
Source:
Air Force Military Medical University, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01665625
