Clinical trial NCT01665625: Regional Versus Systemic Chemotherapy in the Treatment of Unresectable Pancreatic Cancer
Official title: A Prospective Randomized Trial of Regional Versus Systemic Continuous Gemcitabine Chemotherapy in the Treatment of Unresectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Unresectable Pancreatic Cancer
Keywords: Pancreatic cancer
Intra-arterial infusion
Gemcitabine
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2012-08-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: overall surviva
timeFrame: 36 months
Secondary outcomes:
measure: Clinical Benefit Rate
timeFrame: 12 months
measure: The median progression-free survival PFS
timeFrame: 12 months
measure: Drug Toxicity
timeFrame: 18 months
measure: surgical complications
timeFrame: 18 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases, Fourth Military Medical University
state: Shaanxi
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases, Fourth Military Medical University
state: Shaanxi
Study officials:
affiliation: Xijing Hospital of Digestive Diseases, Fourth Military Medical University
name: Guohong Han, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.