Multicenter, open-label, randomised, controlled phase III clinical study of the efficacy and safety of photodynamic therapy using porfimer sodium for injection as palliative treatment for unresectable cholangiocarcinoma
- Conditions
- nresectable CholangiocarcinomaMedDRA version: 7.0Level: LLTClassification code 10008593
- Registration Number
- EUCTR2004-003990-10-GB
- Lead Sponsor
- Axcan Pharma Inc. (Axcan Pharma International B.V. is a subsidiary of Axcan Pharma Inc.)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 166
To be eligible for this study, patients must meet 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the influence of adjuvant photodynamic therapy with porfimer sodium (PORPDT) administered after double plastic endoprostheses (stent) 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.;Secondary Objective: 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; and Health-related Quality of Life (HRQoL).;Primary end point(s): The primary endpoint for this study will be the survival time.<br><br>The secondary efficacy endpoints will involve the assessment of the cholestasis, the one-year survival rate and the HRQoL.
- Secondary Outcome Measures
Name Time Method