New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma

Gallbladder Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01053390
• Other study ID #: xh2009-35
• Status: Completed
• Phase: Phase 3
• First received: January 20, 2010
• Last updated: December 18, 2013
• Start date: October 2009
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gallbladder Neoplasms

Intervention

Drug:
• Somatostatin
Somatostatin 3mg+NS(normal saline)60ml, a continuous intravenous infusion, q12h
• epirubicin, cisplatin, LV(Leucovorin)? 5-FU(5-Fluorouracil)

Locations

Country	Name	City	State
China	Xinhua hospital affiliated shanghai jiaotong	Shanghai

Sponsors (28)

Lead Sponsor

Collaborator

Shanghai Jiao Tong University School of Medicine

Capital Medical University, China Medical University, China, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, Eastern Hepatobiliary Surgery Hospital, First Affiliated Hospital of Chongqing Medical University, Fourth Military Medical University, Jilin University, Kungming the first people’s hospital, LanZhou University, Peking University First Hospital, Qilu Hospital, Qinghai People's Hospital, Qinghai University, Shandong Provincial Hospital, Shanghai Changzheng Hospital, Shengjing Hospital, Southwest Hospital, China, Tang-Du Hospital, The First Affiliated Hospital of Dalian Medical University, The First Affiliated Hospital of Kunming Medical College, The first clinical college of harbin medical university, The first people’s hospital of Guiyang, The people’s hospital of Heilongjiang province, The Second Affiliated Hospital of Harbin Medical University, Tianjin Medical University Cancer Institute and Hospital, Xi'an Center Hospital, Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(Response Evaluation Criteria in Solid Tumors, RECIST,2009 ), CR(complete response) and PR(partial response)		6 month after first treatment	Yes
Secondary	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	Yes