PATIENTS WITH METASTATIC GASTRIC CANCER MedDRA version: 14.1 Level: PT Classification code 10063916 Term: Metastatic gastric cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: MYOCET*INFUS 2SET 50MG
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Doxorubicin
Concentration unit: mg/m2 milligram(s)/square meter
Concentration number: 25-
Sponsors
CENTRO DI RIFERIMENTO ONCOLOGICO DI AVIANO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - DIAGNOSIS OF METASTATIC GASTRIC CARCINOMA - MEASURABLE LESIONS ACCORDING TO RECIST CRITERIA - NO PRIOR SECOND LINE CHEMOTERAPEUTIC TREATMENT - LIFE EXPECTANCY > 3 MONTHS Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - CONCOMITANT SERIOUS DISEASES - NON ADEQUATE CARDIAC FUNCTION - BRAIN METASTASES
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ASSESS THE TREATMENT ACTIVITY IN TERMS OF OBJECTIVE RESPONSE RATE;Secondary Objective: - EVALUATE TIME TO PROGRESSION AND OVERALL SURVIVAL - EVALUATE TOLERABILITY OF THE CHEMOTHERAPEUTIC REGIMEN;Primary end point(s): RESPONSE TO TREATMENT | — |
Countries
Italy
Outcome results
None listed