Health Condition 1: C23- Malignant neoplasm of gallbladder
Conditions
Interventions
Intervention1: Adjuvant chemotherapy + chemoradiation: Cisplatin + Gemcitabine (as per ABC 02 protocol), every 3 weeks for 3 cycles followed by Concurrent chemoradiation (50.4Gy in 28 fractions over 5
Sponsors
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Node positive gallbladder cancer after radical surgery Have an Karnofsky performance status of 80-90. Must be able to start treatment within 6 weeks of surgery Have normal organ and marrow function. No evidence of infection Weight loss not exceeding 10% in the preceding 3 months
Exclusion criteria
Exclusion criteria: R1 resection, non-radical surgery, patients not fit for radical treatment Serious co-existing medical condition likely to interfere with protocol treatment, including a potential serious infection Evidence of significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival Disease free survivalTimepoint: 1 year, 3 year and 5-years | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute toxicitiesTimepoint: 3 months;Quality of lifeTimepoint: Baseline, 3 months, 1 year | — |
Countries
India
Contacts
Public ContactTreshita Dey
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Outcome results
None listed