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Observational Study of Perioperative Chemotherapy in Gastric Cancer

NCT01633203 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 61

Last updated 2020-04-24

No results posted yet for this study

Summary

This study will assess the efficacy and toxicity of perioperative chemotherapy with Epirubicin + Cisplatin + Capecitabine (ECX) in routine clinical practice in a network of public hospitals in Santiago, Chile.

Conditions

Interventions

DRUG

epirubicin + cisplatin + capecitabine polychemotherapy

EPIRUBICIN (LKM)at a dose of 50 mg/m2 over 15 minutes is administered every 21 days. CISPLATIN (LKM) at a dose of 60 mg/m2 over 4 hours is administered every 21 days. Patients must receive standardized hydration per protocol. CAPECITABINE (Xeloda®) at a dose of 625 mg/m2 BID (i.e. 1250 mg/m2/day) 30 minutes after meals from day 1 to day 21 of every cycle of chemotherapy. Antiemetic therapy: * Dexamethasone 8 mg IV and Ondansetron (LKM) 8 mg IV o Granisetron (Kytril®) prior to chemotherapy * Rescue Ondansetron (LKM) 8 mg IV will be given during 24-hour hospitalization in case of emesis * Symptomatic antiemetic therapy with thiethylperazine will be prescribed. Loperamide will be prescribed in case of diarrhea.

Sponsors & Collaborators

  • Grupo Oncologico Cooperativo Chileno de Investigation

    lead NETWORK

Principal Investigators

  • Bettina G Muller, MD · Grupo Oncologico Cooperativo Chileno de Investigation

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2018-03-31
Completion
2018-12-31

Countries

  • Chile

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01633203 on ClinicalTrials.gov