Comparative response evaluation of Cisplatin-Capecitabine with Cisplatin-5-Fluorouracil in advanced gastric carcinoma.

• Register: TCTR
• Last refreshed on: 29 April 2024
• Main ID: TCTR20170715001
• Date of registration: 15/07/2017
• Prospective Registration: Yes
• Primary sponsor: Bangabandhu Sheikh Mujib Medical University
• Public title: Comparative response evaluation of Cisplatin-Capecitabine with Cisplatin-5-Fluorouracil in advanced gastric carcinoma.
• Scientific title: Comparative response evaluation of Cisplatin-Capecitabine with Cisplatin-5-Fluorouracil in advanced gastric carcinoma.
• Date of first enrolment: 20/07/2017
• Target sample size: 62
• Recruitment status: Pending (Not yet recruiting)
• URL: https://www.thaiclinicaltrials.org/show/TCTR20170715001
• Study type: Interventional
• Study design: Randomized
• Phase: N/A

Countries of recruitment

Bangladesh

Contacts

• Name: Ariful Hoque
• Affiliation: Bangabandhu Sheikh Mujib Medical University

• Name: Ariful Hoque
• Affiliation: Bangabandhu Sheikh Mujib Medical University

Key inclusion & exclusion 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: 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.

Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Clinically diagnosed and histopathologically proved advanced gastric carcinoma (AJCC Stage IV).
Advanced gastric carcinoma.

Advanced gastric carcinoma.

Intervention(s)

Cisplatin plus 5-Fluorouracil,Cisplatin plus Capecitabine

Active Comparator Drug,Active Comparator Drug

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 1–14 every 3 weeks.

Primary Outcome(s)

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(s)

Hemoglobin percentage and Neutrophil count Every three weeks Laboratory tests.,Hepatotoxicity and nephrotoxicity Every three weeks Liver and Renal function tests

Secondary ID(s)

1811

Source(s) of Monetary Support

Bangabandhu Sheikh Mujib Medical University

Secondary Sponsor(s)

Dr. Ariful Hoque

Ethics review

Status: Submitted, approved
Approval date:
Contact:

Not available

Institutional Review Board (IRB) of Bangabandhu Sheikh Mujib Medical University

Not available Ext.

Not available

Results

• Date Completed: 31/01/2018