Health Condition 1: null- Locally advance gall bladder cancer patients
Conditions
Interventions
Intervention1: Chemotherapy alone after surgery of gall bladder cancer: Chemotherapy mGEMOX(gemcitabine+oxaliplatin)
or GEMCIS (gemcitabine+oxaliplatin)
Control Intervention1: chemotherapy with concur
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: a. Histologically proven cases of adenocarcinoma of gall bladder b. Patients have undergone radical cholecystectomy by a surgeon with training in gastro-intestinal surgery or a surgical oncologist working in a high-volume center c. Patient has recovered from surgical morbidity d. There is no more than 3 months of time gap between date of radical surgery and start of adjuvant therapy (It is possible to start adjuvant therapy within 3 months of surgery) e. Written consent is obtained f. ECOG Performance status g. Age >18 years h. Adequate bone marrow functions reflected as Hemoglobin� 10gm/dl, TLC �4,000/cmm(ANC�1,500/cmm), and Platelets �1,00,000/cmm) i. Serum creatinine � 1.8 mg% j. Serum bilirubin �3 mg% k. Liver enzymes (SGOT and SGPT) within 3 times the upper normal limit l. No prior exposure to oxaliplatin, oxaliplatin, capecitabine or radiation therapy Exclusion criteria
Exclusion criteria
Exclusion criteria: a. Women of reproductive age group not practicing contraception b. Lactating and pregnant women c. Patients who are on other investigational drugs d. History of previous carcinoma in last 5 yrs. e. Active hepatitis B, C or HIV infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse free survivalTimepoint: till progression or death | — |
Secondary
| Measure | Time frame |
|---|---|
| a Overall survival b Toxicity of chemotherapy and chemo-radiation Timepoint: till progression or death | — |
Countries
India
Contacts
Public ContactDr Atul Sharma
All India Institute of Medical Sciences
Outcome results
None listed