Randomised Phase II study of biweekly versus fractionated triweekly combination Taxotere-Cisplatin-5FU in advanced gastric and gastro-esophageal junction cancer - DoGE01

Phase 1

Conditions: Advanced gastric and oesogastric junction adenocarcinoma
MedDRA version: 9.1Level: SOCClassification code 10017947Term: Gastrointestinal disorders
MedDRA version: 9.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Registration Number: EUCTR2008-000551-10-BE

Lead Sponsor: Institut Jules Bordet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 134

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 < 2
*Hematological examination : Neutrophilic count = 1.5 X 106 / l, Platelets = 100 X 106 / l , Hemoglobin = 11 g / dl
*ASAT/ALAT = 1,5 X ULN , Alkaline Phosphatases < 2,5 ULN
*Bilirubin = 1 X ULN
*Written informed consent
*Clearance creatinine = 60 ml/min (calculated or evaluated by isotopic method)

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

*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