EOADJUVANT EPIRUBICIN-OXALIPLATIN-XELODA AND OXALIPLATIN-XELODA-RADIOTHERAPY IN LOCALLY ADVANCED, RESECTABLE, GASTRIC CANCER. A PHASE II COLLABORATIVE STUDY - NEOX-RT STUDY
- Conditions
- PATIENTS WITH OPERABLE GASTRIC ADENOCARCINOMAMedDRA version: 9.1Level: LLTClassification code 10061968Term: Gastric neoplasm
- Registration Number
- EUCTR2008-002715-40-IT
- Lead Sponsor
- CENTRO DI RIFERIMENTO ONCOLOGICO DI AVIANO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
- PRIOR RADIOTHERAPY OR CHEMOTHERAPY - CLINICALLY SIGNIFICANT CARDIOVASCULAR DISEASES - LACK OF PHYSICAL INTEGRITY OF THE UPPER GASTROINTESTINAL TRACT
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method