To study role of two different chemotherapy regimen and best supportive care in advance not surgically fit gall bladder cancer patient.

a randomizedcontrolled trial comparing:best supportive care versus 5 -FU plus folinic acid versus gemcitabine plus oxaliplatin in unresectable gall bladder cancer.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000015

Enrollment

Registered

2009-02-02

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: null- gall bladder cancer patient not fit for surgery.

Interventions

Intervention1: 5- FU plus folinic acid: folinic acid 20 mg/m2 plus folinic acid 20mg/m2 wkly for maximum 30 cycle. Intervention2: gemcitabine plus oxaliplatin: gemcitabine 900 mg/m2 plus oxaliplatin

Eligibility

Inclusion criteria

Inclusion criteria: histologically proven unresectable gall bladder cancer. normal haematological reserve. bilirubin less than 3 mg % and OT/PT within five times of the normal limits and other normal biochemical profile. age group 18-70 yrs. prior radiotherapy allowed 6 month prior to randomization. prior surgery allowed 4 wks prior to randomization.

Exclusion criteria

Exclusion criteria: patient not giving informed consent pregnancy . performence status(ECOG) >2

Design outcomes

Primary

Measure	Time frame
To compare overall survival between best supportive care versus 5- FU plus folinic acid versus gemcitabine plus oxaliplatin in unresectable gall bladder cancer.Timepoint: 2 1/2 yrs	—

Secondary

Measure	Time frame
To compare progresion free survival between best supportive care versus 5- FU plus folinic acid versus gemcitabine plus oxaliplatin in unresectable gall bladder cancer. To compare toxicities of chemotherapy arms.Timepoint: 2 1/2 yrs	—

Countries

India

Contacts

Public Contactdr atul sharma

atul1@hotmail.com01126589490

Outcome results

None listed

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