New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma
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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 |
- Response Evaluation Criteria in Solid Tumors, RECIST,2009 CR and PR [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
- 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 |
Inclusion Criteria:
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
- Age between 18-75, no gender-based constraints
- Estimated life expectancy ≥12 weeks
- KPS ≥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, 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
- 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)
Exclusion Criteria:
- 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.
Contacts and Locations| Contact: Zhao-hui Tang, MD | 86-21-65790000 ext 7905 | tangzhaohui@yahoo.com |
| China | |
| Xinhua hospital affiliated shanghai jiaotong | Recruiting |
| Shanghai, China | |
| Contact: Zhao-hui Tang, MD 86-21-65790000 ext 7905 tangzhaohui@yahoo.com | |
| 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