New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma

Sponsor

Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT01053390

Collaborator

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 (Other), The Second Affiliated Hospital of Harbin Medical University (Other), Shengjing Hospital (Other), Jilin University (Other), The people's hospital of Heilongjiang province (Other), Eastern Hepatobiliary Surgery Hospital (Other), Shanghai Changzheng Hospital (Other), Shandong Provincial Hospital (Other), 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 (Other), Xi'an Central Hospital (Other), The first people's hospital of Guiyang (Other), Southwest Hospital, China (Other), The First Affiliated Hospital of Kunming Medical College (Other)

216

Enrollment

Location

Arms

Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Objective Primary:

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

Condition or Disease	Intervention/Treatment	Phase
Gallbladder Neoplasms	Drug: Somatostatin Drug: epirubicin, cisplatin, LV（Leucovorin）、 5-FU（5-Fluorouracil）	Phase 3

Detailed Description

Study Design: Treatment, Randomized, Open Label, controlled,Multicenter Group Assignment, Safety/Efficacy Study

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

216 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase III Study of New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: epirubicin,cisplatin,LV（Leucovorin）、5-FU (5-Fluorouracil) conventional regimen	Drug: epirubicin, cisplatin, LV（Leucovorin）、 5-FU（5-Fluorouracil）
Experimental: Somatotatin Conventional chemotherapy regimen plus somatostatin	Drug: Somatostatin Somatostatin 3mg+NS（normal saline）60ml, a continuous intravenous infusion, q12h Drug: epirubicin, cisplatin, LV（Leucovorin）、 5-FU（5-Fluorouracil）

Arm

Intervention/Treatment

Active Comparator: epirubicin,cisplatin,LV（Leucovorin）、5-FU (5-Fluorouracil)

conventional regimen

Drug: epirubicin, cisplatin, LV（Leucovorin）、 5-FU（5-Fluorouracil）

Experimental: Somatotatin

Conventional chemotherapy regimen plus somatostatin

Drug: Somatostatin

Somatostatin 3mg+NS（normal saline）60ml, a continuous intravenous infusion, q12h

Drug: epirubicin, cisplatin, LV（Leucovorin）、 5-FU（5-Fluorouracil）

Outcome Measures

Primary Outcome Measures

(Response Evaluation Criteria in Solid Tumors, RECIST,2009 ), CR(complete response) and PR(partial response) [6 month after first treatment]

Secondary Outcome Measures

A: KPS (karnofsky performance score) B:Laboratory tests: Reexamination of CA19-9（Carbohydrate Antigen 19-9）、 CEA（ carcinoembryonic antigen）, especially for those which are abnormal prior to chemotherapy [6 month after first treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with unresectable locally advanced disease or unresectable local recurrence, including:

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

Age between 18-75, no gender-based constraints
Estimated life expectancy ≥12 weeks
KPS（Karnofsky performance status ）≥60
Each patient gave written informed consent
< 2 previous chemotherapy regimes
No chemotherapy done in the last 4 weeks
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
Patients are required to have histologically confirmed diagnosis via puncture based at least on computed tomography (CT) or ultrasound
Jaundice should be reduced to standard level before chemotherapy (Total bilirubin <5.0 mg/dl)

Exclusion Criteria:

Patients with extensive metastasis and generally poor condition who can not tolerate chemotherapy
Patients who are pregnant or breastfeeding.
Patients with other clinically significant laboratory abnormalities, uncontrolled infection, concurrent severe medical problems unrelated to malignancy
Patients who had a history of previous carcinoma in the last 5 years.
Patients who are allergic to somatostatin or fluorouracil
Patients who refuse chemotherapy, or to sign the informed consent and chemotherapy consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xinhua hospital affiliated shanghai jiaotong	Shanghai		China

Sponsors and Collaborators

Shanghai Jiao Tong University School of Medicine
Xuanwu Hospital, Beijing
Capital Medical University
Peking University First Hospital
Tianjin Medical University Cancer Institute and Hospital
The First Affiliated Hospital of Dalian Medical University
China Medical University, China
The first clinical college of harbin medical university
The Second Affiliated Hospital of Harbin Medical University
Shengjing Hospital
Jilin University
The people's hospital of Heilongjiang province
Eastern Hepatobiliary Surgery Hospital
Shanghai Changzheng Hospital
Shandong Provincial Hospital
Qilu Hospital of Shandong University
Air Force Military Medical University, China
Tang-Du Hospital
Qinghai People's Hospital
Affiliated Hospital of Qinghai University
First Affiliated Hospital of Chongqing Medical University
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
First People's Hospital of Kunming
LanZhou University
Xi'an Central Hospital
The first people's hospital of Guiyang
Southwest Hospital, China
The First Affiliated Hospital of Kunming Medical College