E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Nonresectable hilar or extrahepatic bile duct carcinoma in clinical stage MO ( without liver or peritoneal metastases according to clinical or surgical staging) |
|
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 |
To assess Foscan (temoporfiin) photodynamic therapy tumorocidal penetration greater than 8mm. To assess efficacy and safety of Foscan (temoporfiin) photodynamic therapy in the treatment of locally advanced hilar or extrahepatic bile duct carcinoma without distant metastases. |
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E.2.2 | Secondary objectives of the trial |
- Progression-free survival time, overall survival time - Rate of systemic response (RECIST criteria / EORTC)(37). - Toxicity using WHO criteria and criteria for local toxicity in the biliary system |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
* bile duct carcinoma proven by histology in advanced or non-operable stage or tumor extension: a) Bismuth type 111 or IV ( not resectable with RO-margins ), b) Bismuth type I or II, if resective surgery is contraindicated for old age or poor surgical risk of patient * sufficient general condition to undergo PDT (Karnofsky status 2 30%) * age> 19 years * access to common bile duct (either via endoscopy after sphincterotomy or percutaneously after transhepatic drainage), * informed written consent for PDT. |
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E.4 | Principal exclusion criteria |
* porphyria or other diseases exacerbated by light * known intolerance or allergies to porphyrin derivatives * a planned surgical procedure within the next 30 days * coexisting ophthalmic disease likely to require slit lamp examination within the next 30 days * impaired kidney or liver function (creatinine > 2.5x elevated, INR > 2.2 on vitamin K), * leukopenia ( WBC < 2000/cmm ) or thrombopenia ( < 50000/cmm ), * cytotoxic chemotherapy within the past 4 weeks. * pregnancy ( and safe contraception for 6 months after PDT ) * accompaning/complicating disease with very poor prognosis (expected survival < 6 weeks), * proven advanced peritoneal carcinomatosis (PET scan imaging, ascites positive for tumor cells) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Rate of local response and depth of tumoricidal tissue penetration of Foscan-PDT |
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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 | Information not present in EudraCT |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
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) | No |
E.8.2.2 | Placebo | No |
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.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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
| |
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 | |