The purpose of this study is to find out benefit of two drug chemotherapy versus one drug chemotherapy in Gall bladder cancer

Phase 2

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

• Registration Number: CTRI/2017/10/010112
• 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

1) Patient with advanced unresectable or metastatic GBC cancer that is not amenable to curative intent therapy.

2) Patients should have been treated with palliative intent first line chemotherapy and should have progressed on the same, or stopped 1st line chemotherapy due to poor tolerance, adverse events or other reasons.

3) Age 18 to 70 years.

4) ECOG performance status 0, 1.

5) If the patient has been treated with curative intent therapy, this therapy should have been completed at least 6 months prior to enrolment.

6) Patient who can give informed consent for the study.

7) Patient does not have any contraindications to receive chemotherapy

8) Adequate organ function

1)Hematological- Hb > 90 g/L, ANC >= 1.5 x 109/L, platelets >= 100 x 109/L.

2)Liver functions- bilirubin <= 2 x upper limit normal (ULN), AST/ALT/ ALP <= 2.5 x ULN, S. albumin >= 30 g/L

3)Renal function- Creatinine <= 1.5 ULN, Creatinine clearance > 50 mL/min.

9) Women of child-bearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial.

Exclusion Criteria

1) Serious co-morbidities such as, but not limited to severe cardiac failure severe pulmonary compromise or severe and active infections.

2) History of treatment with 5 FU, Capecitabine or Irinotecan

3) Patients with active second malignancies, apart from skin cancers and cervical intraepithelial neoplasia. The presence of a curatively treated malignancy for which the patient has completed therapy at least 3 years ago and is now in remission for, is considered acceptable.

4) Patients on other investigational drugs within the last 30 days.

Study & Design

• Study Type: Interventional
• Study Design: Not specified