A Randomized, Open, Prospective Clinical Research of Fluorouracil Implant to Improve Surgical Gallbladder Cancer and Bile Duct Cancer
Recruitment status was Recruiting
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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 |
- duration of survival after operation [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- 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 |
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| Contact: Yongjie Zhang, MD | 86-021-81875271 | |
| Contact: Wenlong Yu, MD | 86-021-81875272 |
| 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 | |
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:
|
Bile Duct Neoplasms Gallbladder 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 June 18, 2013