E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced gastric and oesogastric junction adenocarcinoma |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10017947 |
E.1.2 | Term | Gastrointestinal disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10029104 |
E.1.2 | Term | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
evaluate toxicity of a biweekly and a fractionated triweekly regimen of Taxotere-Cisplatin-5FU in advanced gastric and oesogastric junction cancer |
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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)
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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31 evaluable patients need to be registered and assessed in a first step in each arm . In case of strictly less than 7 patients with objective response or strictly more than 8 patients with at least one febrile neutropenic episode, the corresponding arm will be closed prematurely. If at least 7 patients present an objective response and no more than 8 patients develop febrile neutropenia, accrual will be pursued until 67 evaluable patients. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |