CTRI/2016/10/007343
Recruiting
未知
Prospective observational cohort study of advanced Gall bladder cancer patients to study the impact of clinical and molecular characteristics and outcome
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Gall Bladder cancerHealth Condition 2: C23- Malignant neoplasm of gallbladder
- Sponsor
- Tata Memorial Hospital
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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