Clinically diagnosed and histopathologically proved advanced gastric carcinoma (AJCC Stage IV). Advanced gastric carcinoma.
Conditions
Interventions
Cisplatin 80 mg/m2 as a 2 hour i.v. infusion on day 1 with proper hydration plus 5-
FU 800 mg/m2/day by continuous infusion on days 1–5 every 3 weeks.,Cisplatin 80 mg/m2 as a 2 hour i.v. infusion on day 1 with proper hydration plus Oral Capecitabine 1000 mg/m2 twice daily on days 1
Active Comparator Drug,Active Comparator Drug
Cisplatin plus 5-
Fluorouracil,Cisplatin plus Capecitabine
Sponsors
Bangabandhu Sheikh Mujib Medical University
Dr. Ariful Hoque
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Clinically diagnosed and histopathologically proved advanced gastric carcinoma (AJCC Stage IV). 2.At least one measurable lesion, no prior chemotherapy or radiotherapy. 3.Patients with Eastern Cooperative Oncology Group(ECOG) performance status up to 2. 4.Patients within the age limits of 18 to 70 years. 5.Presence of adequate renal, hepatic and cardiac function. Adequate renal function was defined as an estimated Creatinine Clearance Rate ≥60 ml/min using the Cockcroft and Gault formula. Adequate hepatic function was defined as Serum bilirubin ≤1.5 mg/dl, Serum transaminases ≤3 × upper normal limit or ≤5 × upper normal limit in cases of hepatic metastases).
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women. 2.Serious concomitant medical illness including clinically significant cardiovascular disease, uncontrolled diabetes mellitus or hypertension. 3.Evidence of central nervous system metastases. 4.Major surgery of trauma in the previous four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor size Every six weeks Clnical examination and Imaging tests.,Site and number of metastasis Every six weeks Imaging tests.,Pain Every three weeks Wong-Baker FACES Pain Rating Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemoglobin percentage and Neutrophil count Every three weeks Laboratory tests.,Hepatotoxicity and nephrotoxicity Every three weeks Liver and Renal function tests | — |
Countries
Bangladesh
Contacts
Public ContactAriful Hoque
Bangabandhu Sheikh Mujib Medical University
Outcome results
None listed