Regional Versus Systemic Chemotherapy in the Treatment of Unresectable Pancreatic Cancer

Unresectable Pancreatic Cancer Clinical Trial

Official title:

A Prospective Randomized Trial of Regional Versus Systemic Continuous Gemcitabine Chemotherapy in the Treatment of Unresectable Pancreatic Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01665625
• Other study ID #: XHDD 003
• Status: Not yet recruiting
• Phase: N/A
• First received: July 15, 2012
• Last updated: August 10, 2012
• Start date: August 2012
• Est. completion date: February 2016

Study information

• Verified date: August 2012
• Source: Fourth Military Medical University
• Contact: Jun Tie, PH.D., MD
• Phone: +86-29-84771528
• Email: tiejun7776[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: February 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Neoplasms
• Unresectable Pancreatic Cancer

Intervention

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.

Locations

Country	Name	City	State
China	Xijing Hospital of Digestive Diseases, Fourth Military Medical University	Xi'an	Shaanxi
China	Xijing Hospital of Digestive Diseases, Fourth Military Medical University	Xi`an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall surviva		36 months	No
Secondary	Clinical Benefit Rate		12 months	No
Secondary	The median progression-free survival PFS		12 months	No
Secondary	Drug Toxicity	The grading standards of the World Health Organization for acute and subacute toxicity of anticancer drugs will be used to grade toxicity.	18 months	Yes
Secondary	surgical complications	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	Yes