Study to assess effectiveness and side effects of a new chemotherapy combination modified FOLFIRINOX in unresectable Gall Bladder Cancer

Phase 2

• Conditions: Health Condition 1: C23- Malignant neoplasm of gallbladder

• Registration Number: CTRI/2019/02/017562
• Lead Sponsor: ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI

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: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

a.Histologically proven cases of adenocarcinoma of gall bladder

b.Subjects having measurable disease which is considered unresectable or metastatic

c.Written consent is obtained

d.ECOG Performance status < 1.

e.Age >18 years

f.Adequate bone marrow functions reflected as Hb ï?¾ 10gm/dl, TLC ï?¾4,000/cmm ( ANCï?¾1,500/cmm), and Platelets ï?¾1,00,000/cmm)

g.Serum creatinine ï?¼ 1.8 mg%

h.Serum bilirubin ï?¼3 mg%

i.Liver enzymes (SGOT and SGPT) within 3 times the upper normal limit, upto 5 times in case of diffuse liver involvement

j.Prior adjuvant chemotherapy/radiotherapy allowed, provided there is more than 6 months of gap between last chemotherapy/radiotherapy and recurrence

k.Prior radical surgery is allowed if recurrence is unresectable

Exclusion Criteria

a.Women of reproductive age group not practicing contraception

b.Lactating and pregnant women

c.Patients who are on other investigational drugs

d.Patient unwilling to give written informed consent

e.Known history of HIV, hepatitis B or hepatitis C infection

f.Symptomatic neuropathy

g.Uncontrolled concurrent diabetes, hypertension or cardiac disorder

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Overall response rates defined as sum of complete response and partial (CR+PR) <br/ ><br>2.Overall survival defined as date of enrollment to date of death or last seen alive <br/ ><br>Timepoint: January 2019 to December 2019

Secondary Outcome Measures

Name	Time	Method
Toxicity <br/ ><br>Resection ratesTimepoint: January 2019 to December 2019