Status:
TERMINATED
Photodynamic Therapy (PDT) Trial for Palliation of Cholangiocarcinoma
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Cholangiocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This research study is a phase III double arm, multicenter, randomized controlled clinical trial comparing endoscopic retrograde cholangiopancreatography (ERCP) and stenting plus photodynamic therapy ...
Detailed Description
The study objectives are to investigate the efficacy of photodynamic therapy (PDT) in increasing the survival time of patients with unresectable cholangiocarcinoma and to assess the effect of PDT on b...
Eligibility Criteria
Inclusion
- Patient is age 18 years or older
- Patient is diagnosed with non-resectable cholangiocarcinoma, as determined by CT within 30 days of enrollment and CT shows Bismuth Tumor Stage as: IIIa, IIIb, IV (Bismuth tumor stage I and II are not eligible to participate)
- Patients must have adequate organ and marrow function as defined below:
- Patient's INR ≤ 2 within 30 days of treatment
- Patient's platelets \> 50,000/cmm within 30 days of treatment
- Patient's Absolute Neutrophil Count (ANC) \> 1,500/cmm within 30 days of treatment
- Patient's creatinine ≤ 3 mg/dL within 30 days of treatment
- Patient has the ability to understand and the willingness to comply with the study procedures and provide written informed consent to participate in the study
Exclusion
- Patient was diagnosed with cholangiocarcinoma more than 3 months ago
- Patient has any metastatic disease
- Patient has acute porphyria
- Subjects exhibiting neurologic or cutaneous symptoms will undergo urinary delta-aminolevulinic acid and porphobilinogen dosage tests to determine severity.
- Patient is pregnant (Women of child bearing age must have a negative pregnancy test prior to registration and must agree to use adequate contraception during study therapy)
- Patient has a concurrent non solid malignancy
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00907413
Start Date
May 1 2010
End Date
June 1 2011
Last Update
June 3 2015
Active Locations (1)
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1
University of Virginia
Charlotteville, Virginia, United States, 22908