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New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma

This study is currently recruiting participants.
Verified July 2010 by Shanghai Jiao Tong University School of Medicine
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 2nd 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
Xijing Hospital of Fourth Military Medical University
Tangdu hospital of The fourth military medical university
Qinghai povince people’s hospital
Qinghai university affiliated hospital
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 second hospital
Xi'an Center Hospital
The first people’s hospital of Guiyang
Southwest Hospital, China
Xinqiao hospital of the third military medical university
The First Affiliated Hospital of Kunming Medical College
The second affliated hospital of kunming medical college
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01053390
First received: January 20, 2010
Last updated: June 5, 2013
Last verified: July 2010
  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, 5-FU
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 and PR [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • A: KPS (karnofsky performance score) B:Laboratory tests: Reexamination of CA19-9, CEA et al, especially for those which are abnormal prior to chemotherapy [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 260
Study Start Date: October 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: epirubicin,cisplatin,LV,5-FU
conventional regimen
Drug: epirubicin, cisplatin, LV, 5-FU
Experimental: Somatotatin
Conventional chemotherapy regimen plus somatostatin
Drug: Somatostatin
Somatostatin 3mg+NS60ml, a continuous intravenous infusion, q12h
Drug: epirubicin, cisplatin, LV, 5-FU

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 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 (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 T3 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 ≥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, AST ≤ 2.5 times upper limit of normal BUN≤ 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053390

Contacts
Contact: Zhao-hui Tang, MD 86-21-65790000 ext 7905 tangzhaohui@yahoo.com

Locations
China
Xinhua hospital affiliated shanghai jiaotong Recruiting
Shanghai, China
Contact: Zhao-hui Tang, MD     86-21-65790000 ext 7905     tangzhaohui@yahoo.com    
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 2nd 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
Xijing Hospital of Fourth Military Medical University
Tangdu hospital of The fourth military medical university
Qinghai povince people’s hospital
Qinghai university affiliated hospital
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 second hospital
Xi'an Center Hospital
The first people’s hospital of Guiyang
Southwest Hospital, China
Xinqiao hospital of the third military medical university
The First Affiliated Hospital of Kunming Medical College
The second affliated hospital of kunming medical college
Investigators
Study Chair: Zhi-wei Quan, MD Xinhua hospital affiliated shanghai jiaotong university school of medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Zhao-hui Tang,MD, Xinhua hospital affiliated shanghai jiaotong 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: June 5, 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:
Gallbladder Neoplasms
Neoplasms
Carcinoma
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
Somatostatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on June 18, 2013