Clinical trial NCT01053390: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gallbladder Neoplasms
Keywords: gallbladder neoplasmas
Gallbladder Neoplasms,Advanced Stage,Chemotherapy,Somatostatin
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Xuanwu Hospital, Beijing
name: Capital Medical University
name: Peking University First Hospital
name: Tianjin Medical University Cancer Institute and Hospital
name: The First Affiliated Hospital of Dalian Medical University
name: China Medical University, China
name: The first clinical college of harbin medical university
name: The Second Affiliated Hospital of Harbin Medical University
name: Shengjing Hospital
name: Jilin University
name: The people's hospital of Heilongjiang province
name: Eastern Hepatobiliary Surgery Hospital
name: Shanghai Changzheng Hospital
name: Shandong Provincial Hospital
name: Qilu Hospital of Shandong University
name: Air Force Military Medical University, China
name: Tang-Du Hospital
name: Qinghai People's Hospital
name: Affiliated Hospital of Qinghai University
name: First Affiliated Hospital of Chongqing Medical University
name: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: First People's Hospital of Kunming
name: Lanzhou University Second Hospital
name: Xi'an Central Hospital
name: The first people's hospital of Guiyang
name: Southwest Hospital, China
name: First Affiliated Hospital of Kunming Medical University
First posted: 2010-01-21
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: (Response Evaluation Criteria in Solid Tumors, RECIST,2009 ), CR(complete response) and PR(partial response)
timeFrame: 6 month after first treatment
Secondary outcomes:
measure: 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
timeFrame: 6 month after first treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua hospital affiliated shanghai jiaotong
Study officials:
affiliation: Xinhua hospital affiliated shanghai jiaotong university school of medicine
name: Zhi-wei Quan, MD
role: STUDY_CHAIR
References: