New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma

This study has been completed.
Sponsor:
Collaborators:
Xuanwu hospital capital medical university
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
Fourth Military Medical University
Tangdu hospital of The fourth military medical university
Qinghai povince people’s hospital
Qinghai University
First Affiliated Hospital of Chongqing Medical University
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Kungming the first people’s hospital
LanZhou University
Xi'an Center Hospital
The first people’s hospital of Guiyang
Southwest Hospital, China
The First Affiliated Hospital of Kunming Medical College
Information provided by (Responsible Party):
Zhi-wei Quan, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01053390
First received: January 20, 2010
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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

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

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • (Response Evaluation Criteria in Solid Tumors, RECIST,2009 ), CR(complete response) and PR(partial response) [ Time Frame: 6 month after first treatment ] [ Designated as safety issue: Yes ]

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 [ Time Frame: 6 month after first treatment ] [ Designated as safety issue: Yes ]

Enrollment: 216
Study Start Date: October 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01053390

Locations
China
Xinhua hospital affiliated shanghai jiaotong
Shanghai, China
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Xuanwu hospital capital medical university
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
Fourth Military Medical University
Tangdu hospital of The fourth military medical university
Qinghai povince people’s hospital
Qinghai University
First Affiliated Hospital of Chongqing Medical University
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Kungming the first people’s hospital
LanZhou University
Xi'an Center Hospital
The first people’s hospital of Guiyang
Southwest Hospital, China
The First Affiliated Hospital of Kunming Medical College
Investigators
Study Chair: Zhi-wei Quan, MD Xinhua hospital affiliated shanghai jiaotong university school of medicine
  More Information

No publications provided

Responsible Party: Zhi-wei Quan, Professor, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01053390     History of Changes
Other Study ID Numbers: xh2009-35
Study First Received: January 20, 2010
Last Updated: December 18, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Shanghai Jiao Tong University School of Medicine:
gallbladder neoplasmas
Gallbladder Neoplasms,Advanced Stage,Chemotherapy,Somatostatin

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Gallbladder Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Cisplatin
Epirubicin
Fluorouracil
Leucovorin
Levoleucovorin
Somatostatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on July 26, 2014