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

Gallbladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01317069
• Other study ID #: Sinofuan201101
• Status: Recruiting
• Phase: Phase 2
• First received: March 15, 2011
• Last updated: March 15, 2011
• Start date: June 2010
• Est. completion date: April 2013

Study information

• Verified date: March 2011
• Source: Simcere Pharmaceutical Co., Ltd
• Contact: Yongjie Zhang, MD
• Phone: 86-021-81875271
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Bile Duct Cancer
• Bile Duct Neoplasms
• Cholangiocarcinoma
• Gallbladder Cancer
• Gallbladder Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Eastern Hepatobiliary Surgery Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Simcere Pharmaceutical Co., Ltd	Eastern Hepatobiliary Surgery Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of survival after operation		3 years	No
Secondary	disease free survival		1 years	No