E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Unresectable cholangiocarcinoma |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008593 |
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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 |
To assess the influence of adjuvant photodynamic therapy with porfimer sodium (PORPDT) administered after double plastic endoprostheses insertion compared to double plastic endoprostheses insertion alone (palliative medical care) on the overall survival time of patients with unresectable Bismuth type III or IV-tumor stage III or IV cholangiocarcinoma. |
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E.2.2 | Secondary objectives of the trial |
To assess the effect of adjuvant PORPDT administered after double plastic endoprostheses insertion compared to double plastic endoprostheses insertion alone on the following parameters: · Cholestasis · One-year survival rate · Health-related quality of life (HRQoL)
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
To be eligible for this study, patients must meet all of the following criteria:
1. Patients are males or females aged 18 or older.
2. Confirmation of the primary diagnosis by central assessors.
3. Non-menopausal or non-surgically sterilized female patients must have a negative serum beta–HCG at the time of entry into the study and use a medically acceptable form of birth control.
4. Patients must sign an Informed Consent Form, which must comply with the ICH guidelines and local requirements.
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E.4 | Principal exclusion criteria |
Patients with any of the following conditions must be excluded from this trial:
1. Patients who have previously received PDT for cholangiocarcinoma.
2. Patients with known porphyria or known hypersensitivity to porphyrins.
3. Patients who have received chemotherapy, brachytherapy, or radiotherapy during the 90 days prior to randomization.
4. Patients who have previously undergone metal stent insertion.
5. Patients who have previously undergone surgical resection of the cholangiocarcinoma.
6. Patients with any acute or chronic medical or psychological illnesses as judged clinically significant by the investigator to preclude PDT procedure.
7. Patients with current untreated primary diagnosis of anxiety or depression according to the Diagnostic and Statistical Manual of Mental Disorders criteria (DSM IV).
8. Patients with a presence or history of neoplasms (treated during the last five years prior to study entry) other than carcinoma in situ of the cervix or basal carcinoma of the skin.
9. Patients who score less than 30% on the Karnofsky Performance Scale Index.
10. Patients with a white blood cell (WBC) count < 2.0 x 10^9/L, platelet count < 50 x 10^9/L, hemoglobin < 90 g/L, hematocrit < 27%, prothrombin time (PT) expressed as the international normalized ratio (INR) > 2 times the upper limit of normal (ULN) uncorrectable with vitamin K.
11. Patients with decompensated cirrhosis.
12. Patients who have been treated with any investigational drug during 60 days prior to the screening visit.
13. Patients who are unable or unwilling to complete the follow-up evaluations required for the study.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint will be the survival time.
The secondary efficacy endpoints will involve the assessment of the cholestasis, the one-year survival rate and the HRQoL. |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | 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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Compared treatment with PORPDT + Plastic Stents vs. Plastic Stents alone |
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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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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
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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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |