E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Esophagectomy is the surgical removal of all or part of the esophagus. The patients enrolled in the study will undergo this surgery for treatment of esophageal cancer. The condition under investigation is the postoperative inflammatory syndrome (SIRS) after esophagectomy. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Comparasion of the increase of serum IL-6 concentrations at 2 h postoperatively between the treatment group and the placebo group |
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E.2.2 | Secondary objectives of the trial |
Comparasion of the time-courses of serum levels of IL-6, IL-8, IL-10, IL-1β, TNFα and C-reactive protein (CRP) between the treatment group and the placebo group, both in terms of absolute values and values relative to preoperative baseline levels. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Subject has carcinoma of the esophagus that will be treated with esophagectomy 2.Subject is informed and given ample time and opportunity to think about his participation and has given his written informed consent. 3.Subject is willing and able to comply with all trial requirements. |
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E.4 | Principal exclusion criteria |
1.Less than 18 years of age 2.Child-bearing potential 3.Participation in another trial with an investigational product within the last 4 weeks 4.White blood cell count < 4,000 cells/mm³ 5.White blood cell count > 12,000 cells/mm³ 6.Greater than 10% immature neutrophils 7.Body temperature > 38°C 8.Body temperature < 36°C 9.Pulse rate > 90 bpm at eligibility 10.Serum creatinine > 2.0 mg/dL 11.Severe chronic liver disease 12.Severe central nervous system or severe psychiatric disease 13.Impaired spontaneous ventilation 14.Acute myocardial infarction within the last 6 weeks 15.Known heart failure, NYHA Classification III or IV 16.Active infection requiring systemic administration of antibiotics 17.Previous bone marrow transplant 18.Previous organ transplant (heart, kidney, liver) 19.Current immunosuppressive therapy such as cortisone, cyclosporine or azothioprine 20.Cancer-related chemotherapy within the last 2 weeks |
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E.5 End points |
E.5.1 | Primary end point(s) |
The investigator has to withdraw a subject from the trial in the following cases: 1.Occurrence of an AE that does not justify a continuation in the trial 2.Impossibility to obtain samples 3.Protocol deviation that may jeopardize the performance of the trial |
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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 | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
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 | Yes |
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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Final Examination of the last patient undergoing the trial |
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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 | 0 |
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 |