Regional Versus Systemic Chemotherapy in the Treatment of Unresectable Pancreatic Cancer

NCT ID: NCT01665625

Last Updated: 2012-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Unresectable Pancreatic Cancer

Keywords

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Pancreatic cancer Intra-arterial infusion Gemcitabine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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regional interventional chemotherapy group

Group Type EXPERIMENTAL

regional interventional chemotherapy group

Intervention Type PROCEDURE

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.

systemic chemotherapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Guohong Han

Head of Department of Digestive Interventional Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guohong Han, MD

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Locations

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Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Xi'an, Shaanxi, China

Site Status

Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Xi'an, Shaanxi, China

Site Status

Countries

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China

Central Contacts

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Jun Tie, PH.D., MD

Role: CONTACT

Phone: +86-29-84771528

Email: [email protected]

Facility Contacts

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GuoHong Han, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 16412037 (View on PubMed)

Other Identifiers

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XHDD 003

Identifier Type: -

Identifier Source: org_study_id