New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma

NCT01053390 | Completed Phase 3 DMC

• 1 other identifier: xh2009-35
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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

Conditions

Gallbladder Neoplasms

Keywords

gallbladder neoplasmas; Gallbladder Neoplasms,Advanced Stage,Chemotherapy,Somatostatin

Outcome Measures

Primary Outcomes (1)

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

  6 month after first treatment

Secondary Outcomes (1)

• 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

Study Arms (2)

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

ACTIVE COMPARATOR

conventional regimen

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

Somatotatin

EXPERIMENTAL

Conventional chemotherapy regimen plus somatostatin

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

Interventions

Somatostatin DRUG

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

Somatotatin

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

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Xinhua hospital affiliated shanghai jiaotong

Shanghai, China

Location

MeSH Terms

Conditions

Gallbladder Neoplasms

Interventions

Somatostatin; Epirubicin; Cisplatin

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone Release Inhibiting Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pancreatic Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Zhi-wei Quan, MD

  Xinhua hospital affiliated shanghai jiaotong university school of medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 20, 2010
• First Posted: January 21, 2010
• Study Start: October 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 20, 2013

Record last verified: 2013-12

Locations

CN (1)