PRE-OPERATIVE CHEMO-RADIOTHERAPIC TREATMENT IN ESOPHAGEAL AND GASTRO-ESOPHAGEAL JUNCTION ADENOCARCINOMA - ND

Conditions: ESOPHAGEAL AND GASTRO-ESOPHAGEAL JUNCTION ADENOCARCINOMA
MedDRA version: 9.1Level: LLTClassification code 10066350
MedDRA version: 9.1Level: LLTClassification code 10061882
MedDRA version: 9.1Level: PTClassification code 10030137

Registration Number: EUCTR2009-011174-15-IT

Lead Sponsor: AZIENDA OSPEDALIERA PISANA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1 Adenocarcinoma esophagogastric junction histologically proven, II-III-M1 lymphnodal stadium; 2 Male or female, aged > 18 years and < 75 years; 3 ECOG PS < 2 if < 71 years 4 ECOG PS=0 if 71-75 years 5 Adequate bone marrow function: ANC>= 1,5 * 10^3μL; PLT >= 100 * 10^3 μL, Hg >=9 g/dl 6 Adequate hepatic function: bilirubin 1.5 <= UNL, alkaline phosphatase <= 2.5 x UNL AST (SGOT) and ALT (SGPT) <= 2,5 x UNL 7 Adequate renal function: creatinine <= 1,5 x UNL 8 Women of child-bearing potential must agree to use adequate contraceptive methods. 9 Consent form obtained, signed and dated
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

1. Prior adjuvant chemotherapy or radiotherapy; 2. Active uncontrolled infection; 3. Past or current history of neoplasm other than gastric carcinoma, except for curatively treated non melanoma skin cancer or in situ carcinoma of the cervix; 4. Clinically significant cardiovascular disease, for example cerebrovascular accidents (CVA) (≤ 6 months before treatment start), myocardial infarction (≤ 6 months before treatment start), unstable angina, NYHA ≥ grade 2 chronic heart failure (CHF), uncontrolled arrhythmia; 5. Patients with reproductive potential not implementing adequate contraceptive measures; 6 Pregnant or lactating patients; 7. Chronic obstructive pulmonary disease 8. Collagenopathy 9. History of significant psychiatric disorders 10. History of allergy to drugs (or their excipients) used in this study.