Comparative response evaluation of Cisplatin-Capecitabine with Cisplatin-5-Fluorouracil in advanced gastric carcinoma.
- Conditions
- Clinically diagnosed and histopathologically proved advanced gastric carcinoma (AJCC Stage IV).Advanced gastric carcinoma.
- Registration Number
- TCTR20170715001
- Lead Sponsor
- Bangabandhu Sheikh Mujib Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 62
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).
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Hemoglobin percentage and Neutrophil count Every three weeks Laboratory tests.,Hepatotoxicity and nephrotoxicity Every three weeks Liver and Renal function tests