Gallbladder CancerPhase 2NCT01317069
A Randomized, Open, Prospective Clinical Research of Fluorouracil Implant to Improve Surgical Gallbladder Cancer and Bile Duct Cancer
A Phase 2 study testing Fluorouracil implant in people with Gallbladder Cancer and Bile Duct Cancer, run by Simcere Pharmaceutical Co., Ltd at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gallbladder Cancer, Bile Duct Cancer
- What is being tested?
- Fluorouracil implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jun 2010to Apr 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Yongjie Zhang, MD contact
Wenlong Yu, MD contact
China1 site, 1 recruiting
- Recruiting
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai Municipality, 200000
Yongjie Zhang, MD, 86-021-81875271
Wenlong Yu, MD, 86-021-81875272
About this study
Official title: 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.
Read the 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
- 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.
- Conditions
- Gallbladder Cancer, Bile Duct Cancer
- Being tested
- Fluorouracil implant
- Medical subject headings
- Gallbladder Neoplasms, Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorouracil implantDrug
Also called Sinofuan
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
| Study group | Role | What they receive |
|---|---|---|
| Fluorouracil implant | Experimental | Not described Receives: Drug: Fluorouracil implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of survival after operation
Measured: 3 years
Secondary outcomes (1)
disease free survival
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2011 (estimated)
- Study startJun 2010
- Primary completionDec 2012 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Simcere Pharmaceutical Co., Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Eastern Hepatobiliary Surgery Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317069
- Sponsor's protocol ID
- Sinofuan201101
- Status last verified
- Mar 2011
- First submitted
- 15 Mar 2011
- Last updated
- 17 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Prospective Clinical Research Programs of Fluorouracil Implant (Sinofuan) to Improve Surgical Gallbladder Cancer and Bile Duct Cancer
- ClinicalTrials.gov ID
- NCT01317069
- Acronym / sponsor ID
- Sinofuan201101
- Conditions
- Gallbladder Cancer, Bile Duct Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Simcere Pharmaceutical Co., LtdUniversity, hospital or other
- Collaborators
- Eastern Hepatobiliary Surgery Hospital
- Study start
- Jun 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 17 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluorouracil implant | Experimental | Drug: Fluorouracil implant |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluorouracil implantAlso: SinofuanBefore 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 | Drug | Fluorouracil implant |
Primary outcome
duration of survival after operation
Time frame: 3 years
1 secondary outcome
disease free survival
Time frame: 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yongjie Zhang, MD contact
Wenlong Yu, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluorouracil implant in people with Gallbladder Cancer and Bile Duct Cancer, run by Simcere Pharmaceutical Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongjie Zhang, MD (86-021-81875271), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of survival after operation (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2011.