E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
high grade dysplasia and early carcinoma in Barrett Esophagus |
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MedDRA Classification |
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 |
The primary aim of this study is to evaluate the value of photodynamic therapy after complete EMR in patients with prior high-grade dysplasia and mucosal cancer in Barrett’s esophagus. |
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E.2.2 | Secondary objectives of the trial |
· To determine morbidity, mortality, and procedural failure rates, for PDT. · To establish recurrence rates of neoplasia after EMR.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
· All patients Age ≥ 18 years treated for high-grade intraepithelial dysplasia and/or mucosal cancer with EMR, in whom follow-up biopsies do not show remaining severe neoplasia |
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E.4 | Principal exclusion criteria |
· Patients unable or unwilling to give informed consent · A Barrett segment longer than 7 cm · Coagulopathy uncorrected at the time of endoscopy or thrombocytopenia (<50 x 109 / l thrombocytes) · Patients with elevated liver enzymes (more than 2 times the upper limit normal) · Patients with known porphyria, achalasia, intolerance to 5-ALA, connective tissue disease, esophagial atresia, renal insufficiency, pre-existing cardiovascular disease, and prior caustic esophagitis · Patients previously treated for dysplasia or cancer of the esophagus · Patients previously treated with radiotherapy involving the mediastinum or surgical treatment of the esophagus · Pregnant or lactating women, or women of childbearing potential not taking adequate contraceptives
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of this study will be the recurrence rate of histological proven severe dysplasia or cancer after EMR or EMR and PDT. Recurrent disease is defined as the presence of severe neoplastic tissue in either visible recurrent lesions or in random biopsies taken at surveillance endoscopies in the Barrett segment or in the neo-squamous epithelium. The primary endpoint will be measured 3 and 6 month after randomization, and subsequently every 6 months until detection of high grade dysplasia/cancer, or 2 years of follow up. |
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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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
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 | 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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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 |