Malignant neoplasm of cardia
Conditions
Interventions
This is a two-arm, double-blind, randomized controlled clinical trial. A total of 160 patients who meet the eligibility criteria will be probabilistically allocated to one or the other intervention gr
b) Oxaliplatin, for two hours of intravenous infusion, at 85 mg/m2 in 500 ml of 5% glucose
c) Leucovorin, for one hour of intravenous infusion, at 200 mg/m2 in 250 ml of 0.9% sodium chloride
d)5-FU, for 24 hours of intravenous infusion, at 2600 mg/m2. The administration of these four
D02.455.426.559.847.638.721.374.922
Sponsors
Hospital Ophir Loyola
Hospital Ophir Loyola
Eligibility
Age
19 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with locally advanced (T2, T3 or T4) and/or incurable disease; with a performance status between 0 and 2 according to the criteria defined by the Eastern Cooperative Oncology Group or greater than or equal to 60% by the Karnofsky performance status; with adequate organ and bone marrow functions and left ventricular ejection fraction above 50%
Exclusion criteria
Exclusion criteria: Patients with brain metastases, angina, intestinal obstruction, active gastrointestinal bleeding and an estimated life of less than three months; with clinically significant comorbidities that may interfere with treatment tolerance and efficacy; on warfarin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A partial or complete response is expected to be found in at least 50% of patients | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected to find an increase in overall survival in at least 50% of patients;It is expected to confirm the safety of the treatment regimen in 100% of patients | — |
Countries
Brazil
Contacts
Public ContactRommel Burbano
Hospital Ophir Loyola
Outcome results
None listed