To compare the overall survival among patients in relation to different markers Gall bladder cancer

Not Applicable

• Conditions: Health Condition 1: null- Gall Bladder cancerHealth Condition 2: C23- Malignant neoplasm of gallbladder

• Registration Number: CTRI/2016/10/007343
• Lead Sponsor: Tata Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Patients must have histologically confirmed locally advanced inoperable or metastatic adenocarcinoma of the gallbladder who have not previously received any systemic treatment for their disease

ECOG performance status 0-2.

Patients must have adequate organ and marrow function as defined below:

WBC at least 4,000/cmm

ANC at least 2000/cmm

PLT at least 150,000/cmm

Total bilirubin must be less than 2.5 x institutional upper limit of norm

AST(SGOT)/ALT(SGPT) must be less than 5 X institutional upper limit of normal

Creatinine clearance must be greater than 50 mL/min as calculated by the Cockroft-Gault formula

At least one measurable lesion as defined by RECIST criteria

Exclusion Criteria

No concomitant radiation therapy or other systemic cancer therapies.

History of allergy to platinum compounds, capecitabine, or to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy.

Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, thrombolic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months, symptomatic congestive heart failure, unstable angina pectoris within 3 months prior to entry study, myocardial infarction within 6 months prior to study entry, ongoing cardiac arrhythmia (excluding atrial fibrillation), uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg, despite optimal medical management),HIV-positive patients receiving anti-retroviral therapy (HAART) are excluded from the study because of possible pharmacokinetic interactions.

Second malignancy within the past 3 years (excluding nonmelanoma skin cancer and in situ cancers) that has not been treated with curative intent and is not currently without evidence of disease,

Patients with known gastrointestinal malabsorption syndromes are excluded as this concurrent illness will affect absorption of the oral medications.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the overall survival among patients in relation to different markers .And to find out combination of the prognostic and predictive markers in relation to overall survivalTimepoint: 3 year

Secondary Outcome Measures

Name	Time	Method
To compare the progression free survival among in relation to different markersTimepoint: 3 year