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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2016/10/007343
• Date of registration: 06-10-2016
• Prospective Registration: Yes
• Primary sponsor: Tata Memorial Hospital
• Public title: To compare the overall survival among patients in relation to different markers Gall bladder cancer
• Scientific title: Prospective observational cohort study of advanced Gall bladder cancer patients to study the impact of clinical and molecular characteristics and outcome
• Date of first enrolment: 20-10-2016
• Target sample size: 400
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=15343
• Study type: Observational
• Study design: Other; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Vikas Ostwal
• Affiliation: Tata Memorial Hospital

• Name: Vikas Ostwal
• Affiliation: Tata Memorial Hospital

Key inclusion & exclusion 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.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Gall Bladder cancer Health Condition 2: C23- Malignant neoplasm of gallbladder

Primary Outcome(s)

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(s)

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

Secondary ID(s)

1569 Study protocol version 1 dated 29/05/2015

Source(s) of Monetary Support

Unrestricted Educational grants from Merck Private Limited

Ethics review

Status: Approved
Approval date: 21/12/2015
Contact:

Institutional Ethics Committee