- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01665625
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
- Name: Jun Tie, PH.D., MD
- Phone Number: +86-29-84771528
- Email: tiejun7776@163.com
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710032
- Xijing Hospital of Digestive Diseases, Fourth Military Medical University
-
Contact:
- GuoHong Han, MD
- Phone Number: 86-29-84775221
- Email: hangh@fmmu.edu.cn
-
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
|
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.
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.
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
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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