New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma
NCT ID: NCT01053390
Last Updated: 2013-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
216 participants
INTERVENTIONAL
2009-10-31
2013-12-31
Brief Summary
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Determine the objective response rate in patients with advanced gallbladder treated with new Chemotherapy regimen
Secondary:
Determine time to progression-free survival and overall survival of patients treated with this regimen.
Determine quality of life of patients treated with this regimen. Determine the toxicity of new chemotherapy regimen
Detailed Description
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Chemotherapy regimen:
Group A: Conventional chemotherapy regimen Group B: New chemotherapy regimen: conventional regimen plus SST（somatostatin） Cycles repeat every 4 weeks and 6 cycles in total
Patients: A total of 260 patients (130 per group) will be accrued for this study.
Patients distribution:
10patients per center are enrolled in the study and 30 centers (hospitals) in total which meet the total number of patients in trial.
Clinical Outcome Assessments:
Primary: the objective response rate (response evaluation criteria in solid tumors ,RECIST criteria) Secondary: progression-free survival, overall survival, quality of life，the adverse event
Safety Assessments:
Physical exam, laboratory test, probably occurred adverse event.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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epirubicin,cisplatin,LV（Leucovorin）、5-FU (5-Fluorouracil)
conventional regimen
epirubicin, cisplatin, LV（Leucovorin）、 5-FU（5-Fluorouracil）
Somatotatin
Conventional chemotherapy regimen plus somatostatin
Somatostatin
Somatostatin 3mg+NS（normal saline）60ml, a continuous intravenous infusion, q12h
epirubicin, cisplatin, LV（Leucovorin）、 5-FU（5-Fluorouracil）
Interventions
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Somatostatin
Somatostatin 3mg+NS（normal saline）60ml, a continuous intravenous infusion, q12h
epirubicin, cisplatin, LV（Leucovorin）、 5-FU（5-Fluorouracil）
Eligibility Criteria
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Inclusion Criteria
* Patients with unresectable advanced gallbladder cancer （≥ Nevin staging IV or TNM（ tumor node metastasis） classification）
* Patients with complication who have no indication for surgery
* Patients with unresectable local recurrence lesions
2. Age between 18-75, no gender-based constraints
3. Estimated life expectancy ≥12 weeks
4. KPS（Karnofsky performance status ）≥60
5. Each patient gave written informed consent
6. \< 2 previous chemotherapy regimes
7. No chemotherapy done in the last 4 weeks
8. Laboratory test criteria:Haemoglobin ≥ 10g/dl, white blood cell count \> 3,000/mm3 ;Platelet \>100,000/mm3 Total bilirubin \<5.0mg/dl ALT（alanine transaminase）、 AST（aspartate aminotransferase)≤ 2.5 times upper limit of normal BUN（blood urea nitrogen）≤ 2 times upper limit of normal; serum creatinine \<1.5mg/dl: creatinine clearance rate \< 60 ml/min
9. Patients are required to have histologically confirmed diagnosis via puncture based at least on computed tomography (CT) or ultrasound
10. Jaundice should be reduced to standard level before chemotherapy (Total bilirubin \<5.0 mg/dl)
Exclusion Criteria
2. Patients who are pregnant or breastfeeding.
3. Patients with other clinically significant laboratory abnormalities, uncontrolled infection, concurrent severe medical problems unrelated to malignancy
4. Patients who had a history of previous carcinoma in the last 5 years.
5. Patients who are allergic to somatostatin or fluorouracil
6. Patients who refuse chemotherapy, or to sign the informed consent and chemotherapy consent.
18 Years
75 Years
ALL
No
Sponsors
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Xuanwu Hospital, Beijing
OTHER
Capital Medical University
OTHER
Peking University First Hospital
OTHER
Tianjin Medical University Cancer Institute and Hospital
OTHER
The First Affiliated Hospital of Dalian Medical University
OTHER
China Medical University, China
OTHER
The first clinical college of harbin medical university
UNKNOWN
The Second Affiliated Hospital of Harbin Medical University
OTHER
Shengjing Hospital
OTHER
Jilin University
OTHER
The people's hospital of Heilongjiang province
UNKNOWN
Eastern Hepatobiliary Surgery Hospital
OTHER
Shanghai Changzheng Hospital
OTHER
Shandong Provincial Hospital
OTHER_GOV
Qilu Hospital of Shandong University
OTHER
Air Force Military Medical University, China
OTHER
Tang-Du Hospital
OTHER
Qinghai People's Hospital
OTHER
Affiliated Hospital of Qinghai University
OTHER
First Affiliated Hospital of Chongqing Medical University
OTHER
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
OTHER
First People's Hospital of Kunming
OTHER
Lanzhou University Second Hospital
OTHER
Xi'an Central Hospital
OTHER
The first people's hospital of Guiyang
UNKNOWN
Southwest Hospital, China
OTHER
First Affiliated Hospital of Kunming Medical University
OTHER
Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Zhi-wei Quan
Professor
Principal Investigators
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Zhi-wei Quan, MD
Role: STUDY_CHAIR
Xinhua hospital affiliated shanghai jiaotong university school of medicine
Locations
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Xinhua hospital affiliated shanghai jiaotong
Shanghai, , China
Countries
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Other Identifiers
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xh2009-35
Identifier Type: -
Identifier Source: org_study_id