Health Condition 1: null- Carcinoma Gall Bladder with obstructive jaundice
Conditions
Interventions
Intervention1: Gemcitabine and capecitabine: Palliative chemotherapy in Unresectable Carcinoma Gall bladder patients with obstructive jaundice post PTBD/Stenting
Control Intervention1: Gemcitabine and
Sponsors
AIIMS
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with biopsy or cytology proven unresectable or metastatic carcinoma gall bladder with obstructive jaundice. 2. Limited liver or peritoneal metastases with good performance status (ECOG Adequate organ and bone marrow function. 3. Haemoglobin more than 10 g/dl, absolute neutrophil count more than 1.5Ã?109/L, platelets higher than 100 Ã? 109/L. 4. Serum creatinine 5. Serum bilirubin 6. Eastern Cooperative Oncology Group performance status of 7. Prior adjuvant chemotherapy and/or radiotherapy, if given, should have been completed 6 months before enrollment
Exclusion criteria
Exclusion criteria: 1 Diffuse metastases in the liver or disseminated disease 2. Gross ascites
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess and compare the quality of life of both groups.Timepoint: none | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess and compare the quality of life of bothTimepoint: Over one year;To assess the role of PTBD and chemotherapy on survival and quality of life with asymptomatic obstructive jaundice.Timepoint: Till death;To assess treatment-related complications of chemotherapy.Timepoint: Over a period of six months that is within one month of last chemotherapy cycle app 6 months.;To compare progression free survival in both groups.Timepoint: 6 months and derafter every 3 monthly. | — |
Countries
India
Contacts
Public ContactMohammed Adil Asfan
AIIMS
Outcome results
None listed