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) |
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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 |
To assess efficacy and safety of FoscanB (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 | |