New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma

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

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

Study Overview

• Status: Completed
• Conditions: Gallbladder Neoplasms
• Intervention / Treatment: Drug: epirubicin, cisplatin, LV（Leucovorin）、 5-FU（5-Fluorouracil）; Drug: Somatostatin

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 Type: Interventional
• Enrollment (Actual): 216
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Xinhua hospital affiliated shanghai jiaotong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: epirubicin, cisplatin, LV（Leucovorin）、 5-FU（5-Fluorouracil）; Drug: Somatostatin; Somatostatin 3mg+NS（normal saline）60ml, a continuous intravenous infusion, q12h

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
(Response Evaluation Criteria in Solid Tumors, RECIST,2009 ), CR(complete response) and PR(partial response)	6 month after first treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: January 20, 2010
• First Submitted That Met QC Criteria: January 20, 2010
• First Posted (Estimate): January 21, 2010

Study Record Updates

• Last Update Posted (Estimate): December 20, 2013
• Last Update Submitted That Met QC Criteria: December 18, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: gallbladder neoplasmas; Gallbladder Neoplasms,Advanced Stage,Chemotherapy,Somatostatin
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gallbladder Diseases; Biliary Tract Diseases; Biliary Tract Neoplasms; Gallbladder Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protective Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Micronutrients; Antibiotics, Antineoplastic; Vitamins; Antidotes; Vitamin B Complex; Fluorouracil; Epirubicin; Leucovorin; Somatostatin
• Other Study ID Numbers: xh2009-35