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

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: Bile Duct Cancer; Gallbladder Cancer
• Intervention / Treatment: Drug: Fluorouracil implant

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

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

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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

1

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	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
disease free survival	1 years

Collaborators and Investigators

• Sponsor: Simcere Pharmaceutical Co., Ltd
• Collaborators: Eastern Hepatobiliary Surgery Hospital

Study record dates

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: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Gallbladder Diseases; Biliary Tract Diseases; Bile Duct Diseases; Biliary Tract Neoplasms; Cholangiocarcinoma; Gallbladder Neoplasms; Bile Duct Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Fluorouracil
• Other Study ID Numbers: Sinofuan201101