Advanced gastric and oesogastric junction adenocarcinoma MedDRA version: 9.1 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders MedDRA version: 9.1 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: TAXOTERE
Product Name: Taxotere 80mg/2ml
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: cisplatin
CAS Number: 15663271
Other descriptive name: Platosin
Con
Sponsors
Institut Jules Bordet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: *Histologically proven chemotherapy-naïve advanced adenocarcinoma of the stomach, esogastric junction, or esophagus. *Patients with locally advanced inoperable tumors rendered operable by chemotherapy, could be operated on. *evaluable lesions *A previous adjuvant chemotherapy for gastric cancer is authorized if the tumor has not progressed during or 6 months after chemotherapy administration, provided it contains no cisplatin. *Age = 18 years *Performance status =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: *Unwillingness to take anticonceptional means for women in procreating age *Ongoing pregnancy or lactation. *Uncontrolled Central nervous system metastasis. *History of another concomitant malignant disease with the exception of in situ cervix carcinoma or non-melanoma skin cancer *Participation to another clinical study within 4 weeks before inclusion in this study *Concomitant antineoplasic treatment. *Previous use in adjuvant setting of more than 400 mg/m² (total cumulated dose) cisplatin *Known deficiency in DPD or allergy to one or more drugs of the study *History of other uncontrolled life-threatening or severe disease *Uncontrolled infectious disease. *Impossibility to assure an adequate follow-up due to psychological, familial, social and/or geographic reasons. *Liver tests: Bilirubin > 1 x upper limit of normal (ULN), SASAT and/or SALAT >1.5 x ULN concomitant with alkaline Phosphatases > 2.5 x ULN. *Clearance creatinine < 60 ml/min *Uncontrolled angina pectoris or myocardial infarction < 6 weeks before beginning of the chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: evaluate toxicity of a biweekly and a fractionated triweekly regimen of Taxotere-Cisplatin-5FU in advanced gastric and oesogastric junction cancer;Secondary Objective: a) Evaluation of the efficacy in both regimen based on an outpatient administration. b) Evaluation of survival c) Evaluation of progression free survival d) Translational research ;Primary end point(s): evaluate toxicity of a biweekly and a fractionated triweekly regimen of Taxotere-Cisplatin-5FU in advanced gastric and oesogastric junction cancer | — |
Countries
Belgium
Outcome results
None listed