A study to compare the efficacy of Gemcitabine and Capecitabine in metastatic locally advanceed Gall Bladder Cancer

A RANDOMIZED PROSPECTIVE OPEN LABEL STUDY COMPARING SINGLE AGENT GEMCITABINE VERSUS CAPECITABINE IN PATIENTS OF LOCALLY ADVANCED AND METASTATIC CARCINOMA GALL BLADDER WITH POOR PERFORMANCE STATUS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/05/019005

Enrollment

100

Registered

2019-05-09

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C23- Malignant neoplasm of gallbladder

Interventions

Intervention1: ARM B: Oral Capecitabine @ 825 mg/ mÂ² twice daily 30 minutes after food for continuous 14 days followed by 7 days gap and cycles will be repeated every 3 weekly for four cycles. Contro

Eligibility

Inclusion criteria

Inclusion criteria: ECOG performance score more than equals to 2. Written informed consent Staging done prior to randomization. Creatinine levels indicating renal clearance more than or equals to 50 ml/min. Bilirubin less than 3 times of upper normal limit. Biopsy/FNAC proven Gall Bladder adenocarcinoma Locally advanced unresectable tumours or Metastatic disease.

Exclusion criteria

Exclusion criteria: Recurrent gall bladder cancer. Inability to give informed consent. Previous history of hepatobiliary cancers Medical comorbidities precluding use of chemotherapy. Concomitant malignancies.

Design outcomes

Primary

Measure	Time frame
To compare progression free survival and overall survival in both chemotherapy groups.Timepoint: 1 year after completing recruitment	—

Secondary

Measure	Time frame
To compare the toxicity profile and rate of completion of planned number of chemotherapy cycles (i.e. compliance) between the two groupsTimepoint: during treatment and on follow up.	—

Countries

India

Contacts

Public ContactGAURAV KUMAR

DR. B BOROOAH CANCER INSTITUTE

bhargabjyotisaikia@gmail.com9864020967

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026