Doublet chemotherapy (Gemcitabine and Cisplatin) vs triplet chemotherapy (Gemcitabine, Cisplatin and Nab-paclitaxel) in locally advanced or metastatic gall bladder cancer patients.
Phase 2
- Conditions
- Health Condition 1: C23- Malignant neoplasm of gallbladder
- Registration Number
- CTRI/2021/09/036362
- Lead Sponsor
- Dr Chandrani Khatri
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1)Locally advanced or metastatic gall bladder cancer patients proven histologically and on imaging [contrast enhanced CT scan of chest, abdomen and pelvis / MRI abdomen and pelvis with CECT chest /whole body PET CT scan]
2)ECOG performance 0-2
3)Adequate renal functions [Creatinine Clearance >60mL/min]
4)Adequate hepatic functions [serum bilirubin <1.5 ULN and SGOT/SGPT < 10 ULN.
5)Adequate hematological parameters [ Hemoglobin >8g/dL , platelet count > 1 lakh, ANC >1500/ul]
Exclusion Criteria
1)Patients who fail to give consent
2)Patients who have received prior systemic chemotherapy for current malignancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PRIMARY OBJECTIVE: To determine the Response Rate (RR) based on Radiological Response as per RECIST or PRECIST.Timepoint: Response Rate - Complete response or partial response as per RECIST or PRECIST after 3 and after 6 cycles of chemotherapy.
- Secondary Outcome Measures
Name Time Method SECONDARY OBJECTIVES: <br/ ><br>1.To determine Progression Free Survival (PFS) and Overall Survival (OS) <br/ ><br>2.To evaluate the toxicities according to NCI-CTC v 4.0. <br/ ><br>3.To correlate clinico-demographic profile and laboratory features. <br/ ><br>Timepoint: 1.Progression free survival at 6 months, at 12 months and at 18 months and Overall survival at 6 months, at 12 months and at 18 months. <br/ ><br>2.Toxicities according to NCI-CTC V 4.0 after each cycle of chemotherapy then at 6 months, at 12months and at 18 months. <br/ ><br>3. Clinico-demographic profile will be recorded at baseline and serum tumors marker ( CA 19.9) will be recorded at baseline, after 3 cycles and 6 cycles and at 6 months,at 12 months ,at 18 months follow up. <br/ ><br>