PATIENTS WITH OPERABLE GASTRIC ADENOCARCINOMA MedDRA version: 9.1 Level: LLT Classification code 10061968 Term: Gastric neoplasm
Conditions
Interventions
Trade Name: FARMORUBICINA
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Epirubicin
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concen
Sponsors
CENTRO DI RIFERIMENTO ONCOLOGICO DI AVIANO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - PTS WITH HISTOLOGICALLY CONFIRMED GASTRIC ADENOCARCINOMA - PTS WITH T3 OR T4 CARCINOMA WITH N0 AND ANY T STAGE WITH N+ DETERMINATED BY ENDOSCOPIC ULTRASONOGRAPHY ALONE - NO DISTANT METASTASES - A STAGING LAPAROSCOPY IS MANDATORY TO ASSESS THE RISK OF PERITONEAL CARCINOMATOSIS Are the trial subjects under 18? no Number of subjects for this age range: 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: - PRIOR RADIOTHERAPY OR CHEMOTHERAPY - CLINICALLY SIGNIFICANT CARDIOVASCULAR DISEASES - LACK OF PHYSICAL INTEGRITY OF THE UPPER GASTROINTESTINAL TRACT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: THE PATHOLOGICAL COMPLETE RESPONSE RATE OF THIS NEOADJUVANT CHEMO-RADIOTHERAPY PROGRAM IN OPERABLE LOCALLY ADVANCED ADENOCARCINOMA PATIENTS;Secondary Objective: -ASSESS THE FEASIBILITY OF THIS COMBINED MODALITY PROGRAM -ASSESS THE CURATIVE RESECTION RATE R0;Primary end point(s): THE PATHOLOGICAL COMPLETE RESPONSE RATE OF THIS NEOADJUVANT CHEMO-RADIOTHERAPY PROGRAM IN OPERABLE LOCALLY ADVANCED ADENOCARCINOMA PATIENTS | — |
Countries
Italy
Outcome results
None listed