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

NCT01317069 | Unknown Phase 2

• 1 other identifier: Sinofuan201101
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gallbladder Cancer; Bile Duct Cancer

Outcome Measures

Primary Outcomes (1)

• duration of survival after operation

  3 years

Secondary Outcomes (1)

• disease free survival

  1 years

Study Arms (1)

Fluorouracil implant

EXPERIMENTAL

Drug: Fluorouracil implant

Interventions

Fluorouracil implant DRUG

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

Also known as: Sinofuan

Fluorouracil implant

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Simcere Pharmaceutical Co., Ltd: lead
• Eastern Hepatobiliary Surgery Hospital: collaborator

Study Sites (1)

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Gallbladder Neoplasms; Bile Duct Neoplasms

Interventions

Fluorouracil

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Bile Duct Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Yongjie Zhang, MD

CONTACT

86-021-81875271

Wenlong Yu, MD

CONTACT

86-021-81875272

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 15, 2011
• First Posted: March 17, 2011
• Study Start: June 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: April 1, 2013
• Last Updated: March 17, 2011

Record last verified: 2011-03

Locations

CN (1)