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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Simcere Pharmaceutical Co., Ltd.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Eastern Hepatobiliary Surgery Hospital
Information provided by:
Simcere Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01317069
First received: March 15, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Gallbladder Cancer
Bile Duct Cancer
Drug: Fluorouracil implant
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open, Prospective Clinical Research Programs of Fluorouracil Implant (Sinofuan) to Improve Surgical Gallbladder Cancer and Bile Duct Cancer

Resource links provided by NLM:


Further study details as provided by Simcere Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • duration of survival after operation [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • disease free survival [ Time Frame: 1 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Sinofuan

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01317069

Contacts
Contact: Yongjie Zhang, MD 86-021-81875271
Contact: Wenlong Yu, MD 86-021-81875272

Locations
China, Shanghai
Eastern Hepatobiliary Surgery Hospital Recruiting
Shanghai, Shanghai, China, 200000
Contact: Yongjie Zhang, MD    86-021-81875271      
Contact: Wenlong Yu, MD    86-021-81875272      
Principal Investigator: Yongjie Zhang, MD         
Sponsors and Collaborators
Simcere Pharmaceutical Co., Ltd
Eastern Hepatobiliary Surgery Hospital
  More Information

No publications provided

Responsible Party: Yongjie Zhang MD, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier: NCT01317069     History of Changes
Other Study ID Numbers: Sinofuan201101
Study First Received: March 15, 2011
Last Updated: March 15, 2011
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Gallbladder Neoplasms
Bile Duct Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Bile Duct Diseases
Fluorouracil
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014