Adenocarcinoma of cardias siewert III MedDRA version: 20.0 Level: LLT Classification code 10001187 Term: Adenocarcinoma of the cardia System Organ Class: 100000004864
Conditions
Interventions
Trade Name: TAXOTERE - 20 MG CONCENTRATO PER INFUSIONI IV + SOLVENTE
Product Name: TAXOTERE
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: DOCETAXEL
CAS Number: 114977
Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The inclusion criteria proposed are as follows: • Locally advanced carcinomas:> cT2N0 or any cT if cN + (TNM 7th - APPENDIX A) • Ability to provide specific informed consent in order to be admitted to the study • Males and Females aged 18 to 75 years (=18 and = 75 years). Female subjects of childbearing age, according to CTFG guidelines, will undergo a pregnancy test that will have to be negative in the days immediately preceding the start of treatment. In addition, all subjects must agree to use an effective contraceptive method during and for the next 6 months from the date of treatment initiation • Good Performance Status (ECOG = 2 - APPENDIX B) • Cardiac Siewert III endoscopic neoplasia diagnosis • Anatomopathological diagnosis with histophyllus sec. Lauren 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 64 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 22
Exclusion criteria
Exclusion criteria: The exclusion criteria proposed are as follows: • Non-advanced carcinoma cT1-T2N0 (TNM 7th - APPENDIX A) • Presence of remote metastases • Chemio-radiotherapy treatments over the past 5 years • Altered renal function (creatinine = 1.5 UNL, or in case of borderline clearance of creatinine calculated = 60 mL / min), • Altered liver function (total bilirubin = 1.25 UNL, AST (SGOT) and ALT (SGPT) = 2.5 UNL, alkaline phosphatase <2.5 UNL, • Alteration of haemopoietic function (neutrophils = 1.5 x 109 / L, platelets = 100 x 109 / L, hemoglobin = 10g / dL), • Women and men of childbearing age who do not use appropriate contraceptives, • Pregnant women, • Women during breastfeeding, • Patients in an emergency, • Patients who take: compounds that induce or inhibit cytochrome P450-3A or which come from this metabolised such as cyclosporine, terfenadine, ketoconazole, erythromycin and troleandomycin; carboplatin; prednisone; Active medicines on cytochrome P-450 2C9 substrates such as phenytoin; Anti-inflammatory coumarin derivatives (for example warfarin and phenprocoumone); Folinic acid / folic acid; Sorivudine and Similar (5-FU); antacids; allopurinol; Interferon alfa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Overall survival (OS) after 3 years of enrollment, expressed as a percentage of patients living at 3 years;Secondary Objective: Overall Survival (OS - Overall Survival) at 5 years from enrollment DFS - disease free survival Treatment-related toxicity Percentage of Radical Surgery (R0) Surgery Morbidity-Mortality;Primary end point(s): Overall survival (OS) over 3 years from enrollment;Timepoint(s) of evaluation of this end point: 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): global survival after 5 years from enrollment; disease free survival; Treatment-related toxicity, which will be evaluated as absolute frequency and percentage of patients with one or more adverse events during treatment; Percentage of Radical Surgery (R0), which indicates a resection with free margins of neoplastic infiltration resection to the macroscopic (R1) and to the microscopic (R0) examination; Surgery Morbidity-Mortality. Surgical morbidity will be related to surgical complications (abscesses, fistulas, suture deities). Surgical mortality will be evaluated within 30 days from surgery or mortality during hospitalization;Timepoint(s) of evaluation of this end point: 5 years; during 5 years; during treatment; post surgery; 30 days after surgery | — |
Countries
Italy
Contacts
Public ContactUnità ricerca clinica
azienda ospedaliera integrata universitaria di verona
Outcome results
None listed