Health Condition 1: C23- Malignant neoplasm of gallbladder
Conditions
Interventions
Intervention1: chemotherapy followed by chemoradiation arm followed by chemotherapy: Chemotherapy Capecitabine PO Every 21 days 2 to 4 cycles followed by
Concurrent chemoradiation EBRT with capecitab
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: -Histologically confirmed adenocarcinoma of the gallbladder post resection -No radiological or clinical evidence of metastatic disease -No metastatic disease as discovered by on-table evaluation during definitive surgery for GBC peritoneal disease, liver metastases etc -R0/R1 resection -ECOG performance status 0 - 1 -Patient does not have any contraindications to receive chemotherapy -Adequate hematological, hepatic and renal function parameters -Women of childbearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment Written patient consent form -Able to read, write and understand either Hindi, English, Marathi, or Bengali.
Exclusion criteria
Exclusion criteria: -R2 surgical resections -Known hypersensitivity or contraindications against gemcitabine, cisplatin, or capecitabine -Clinically significant active coronary heart disease, cardiomyopathy, valvular heart disease or congestive heart failure, NYHA III-IV -Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix Evidence of sensorineural hearing loss more than or equal too moderate degree as per pure tone audiometry -Other severe internal disease or acute infection -Baseline neuropathy NCI CTCAE version 4 Grade I -Chronic inflammatory bowel disease -On-treatment participation in another clinical study in the period 30 days prior to inclusion and during the study. -Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess 1 year disease-free survival in two armsTimepoint: 2 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 3 year Overall Survival Quality of life Completion rates Toxicity and side-effect profile Recurrence patterns local and locoregional versus systemic Timepoint: 3 year OS all other endpoint 2 year | — |
Countries
India
Contacts
Public ContactAnant Ramaswamy
Tata Memorial Hospital
Outcome results
None listed