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New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma

Primary Purpose

Gallbladder Neoplasms

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Somatostatin
epirubicin, cisplatin, LV（Leucovorin）、 5-FU（5-Fluorouracil）
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gallbladder Neoplasms focused on measuring gallbladder neoplasmas, Gallbladder Neoplasms,Advanced Stage,Chemotherapy,Somatostatin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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
  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:

  1. Patients with extensive metastasis and generally poor condition who can not tolerate chemotherapy
  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.

Sites / Locations

  • Xinhua hospital affiliated shanghai jiaotong

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

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

Somatotatin

Arm Description

conventional regimen

Conventional chemotherapy regimen plus somatostatin

Outcomes

Primary Outcome Measures

(Response Evaluation Criteria in Solid Tumors, RECIST,2009 ), CR(complete response) and PR(partial response)

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

Full Information

First Posted
January 20, 2010
Last Updated
December 18, 2013
Sponsor
Shanghai Jiao Tong University School of Medicine
Collaborators
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, Second Hospital of Lanzhou University, Xi'an Central Hospital, The first people's hospital of Guiyang, Southwest Hospital, China, First Affiliated Hospital of Kunming Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01053390
Brief Title
New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma
Official Title
A Phase III Study of New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
Collaborators
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, Second Hospital of Lanzhou University, Xi'an Central Hospital, The first people's hospital of Guiyang, Southwest Hospital, China, First Affiliated Hospital of Kunming Medical University

4. Oversight

Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallbladder Neoplasms
Keywords
gallbladder neoplasmas, Gallbladder Neoplasms,Advanced Stage,Chemotherapy,Somatostatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
epirubicin,cisplatin,LV（Leucovorin）、5-FU (5-Fluorouracil)
Arm Type
Active Comparator
Arm Description
conventional regimen
Arm Title
Somatotatin
Arm Type
Experimental
Arm Description
Conventional chemotherapy regimen plus somatostatin
Intervention Type
Drug
Intervention Name(s)
Somatostatin
Intervention Description
Somatostatin 3mg+NS（normal saline）60ml, a continuous intravenous infusion, q12h
Intervention Type
Drug
Intervention Name(s)
epirubicin, cisplatin, LV（Leucovorin）、 5-FU（5-Fluorouracil）
Primary Outcome Measure Information:
Title
(Response Evaluation Criteria in Solid Tumors, RECIST,2009 ), CR(complete response) and PR(partial response)
Time Frame
6 month after first treatment
Secondary Outcome Measure Information:
Title
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
Time Frame
6 month after first treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhi-wei Quan, MD
Organizational Affiliation
Xinhua hospital affiliated shanghai jiaotong university school of medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Xinhua hospital affiliated shanghai jiaotong
City
Shanghai
Country
China

12. IPD Sharing Statement

Learn more about this trial

New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma

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