A Randomized, Open, Prospective Clinical Research of Fluorouracil Implant to Improve Surgical Gallbladder Cancer and Bile Duct Cancer

March 15, 2011 updated by: Simcere Pharmaceutical Co., Ltd

A Randomized, Open, Prospective Clinical Research Programs of Fluorouracil Implant (Sinofuan) to Improve Surgical Gallbladder Cancer and Bile Duct Cancer

Through clinical practice, to explore if the application of Fluorouracil implant could effectively delay the local tumor recurrence and improvement the postoperative survival time in patients with gallbladder cancer and bile duct cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Major Objective Through clinical practice, to explore if the application of Fluorouracil implant could effectively delay the local tumor recurrence and improvement the postoperative survival time in patients with gallbladder cancer and bile duct cancer.

Secondary objective

1) If Fluorouracil implants application in clinical surgery could lead to the incidence of complications increased in biliary-enteric anastomosis.

2）Assess drug safety according to drug-related clinical and / or laboratory adverse events.

3）Observe the postoperative complication rate of Fluorouracil implants. 4）Observe the quality of life of patients used Fluorouracil implants.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Eastern Hepatobiliary Surgery Hospital
        • Contact:
          • Yongjie Zhang, MD
          • Phone Number: 86-021-81875271
        • Contact:
          • Wenlong Yu, MD
          • Phone Number: 86-021-81875272
        • Principal Investigator:
          • Yongjie Zhang, 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 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patients with gallbladder and bile duct cancer diagnosis by surgical exploration, or intraoperative frozen biopsy (Annex 2).
  • Aged 18 to 70 years old, male or female, body condition score generally ECOG 0～2, expected survival ≥ 3 months.
  • Subjects were no major organ dysfunction, blood, liver, kidney and heart function was normal, the specific requirements of laboratory indicators:

Blood: WBC count > 3.0 × 109 / L, Platelet count> 100 × 109 / L, Hb > 8.0g/dl. Liver function：serum bilirubin less than 1.5 times the upper limit of normal; ALT and AST less than 3 times the upper limit of normal.

Renal function: creatinine less than 1.5 times the upper limit of normal.

  • Participants have used other chemotherapy drugs, subject to the 30-day washout period before proceeding with the test.
  • Patients had no anaphylactic reaction with oxaliplatin and fluorouracil in the past.
  • Patients who can understand the circumstances of this study and signed informed consent.

Exclusion Criteria:

  • Currently is receiving effective treatment；
  • Pregnancy, breast-feeding patients；
  • Primary brain tumors or central nervous system metastatic tumor is not controlled;
  • Patients received chemotherapy, radiotherapy, biological therapy, other drugs or instrument therapy 30 days before enrollment.
  • Patients with purulent and chronic infected wounds which delayed healing.
  • Patients with liver, kidney and heart failure and coronary heart disease, angina, myocardial infarction, arrhythmia, cerebral thrombosis, stroke and other serious cardiovascular and cerebrovascular disease;
  • Patients has a history of mental illness and difficult to control;
  • Patients who was considered inappropriate to participate in the trials by the researchers.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Fluorouracil implant
Drug: Fluorouracil implant
Before the abdomen was closed, fluorouracil implant 1000mg was sprayed evenly on the surface of tumor resection area, and some of the drugs were put into mesenteric root based on the location
Other Names:
  • Sinofuan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
duration of survival after operation
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
disease free survival
Time Frame: 1 years
1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Simcere Pharmaceutical Co., Ltd

Collaborators

Eastern Hepatobiliary Surgery Hospital

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

June 1, 2010

Primary Completion (ANTICIPATED)

December 1, 2012

Study Completion (ANTICIPATED)

April 1, 2013

Study Registration Dates

First Submitted

March 15, 2011

First Submitted That Met QC Criteria

March 15, 2011

First Posted (ESTIMATE)

March 17, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 17, 2011

Last Update Submitted That Met QC Criteria

March 15, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sinofuan201101

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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