PATIENTS WITH LOCALLY ADVANCED UNRESECTABLE OR METASTATIC GASTRIC CANCER MedDRA version: 9.1 Level: LLT Classification code 10001150 Term: Adenocarcinoma gastric
Conditions
Interventions
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Epirubicin
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 40-
Pharmaceutical Form:
Sponsors
AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Signed written informed consent - Male or female =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Concurrent chronic systemic immune therapy - Any investigational agent(s) 4 weeks prior to entry - Known grade 3 or 4 allergic reaction to any of the components of the treatment - Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent - Women who are pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Therapeutic activity of 2 different regimens (EOX vs TOX) in patients with unresectable and/or metastatic gastric cancer. The primary activity parameter to be determined is Overall Response Rate (RECIST Criteria).;Secondary Objective: Overall Survival time (OS) Progression Free Survival (PFS) Safety;Primary end point(s): Response rate (RECIST criteria) | — |
Countries
Italy
Outcome results
None listed