Clinical trial NCT00907413: Photodynamic Therapy (PDT) Trial for Palliation of Cholangiocarcinoma
Official title: Photodynamic Therapy for Palliation of Unresectable Cholangiocarcinoma A Multicenter, Open Label, Randomized, Controlled Phase III Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cholangiocarcinoma
Keywords: cancer
bile duct
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2009-05-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (PDT) versus ERCP with stenting alone in adult patients with unresectable cholangiocarcinoma.

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 both cholestasis and health-related quality of life (HRQoL).

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 both cholestasis and health-related quality of life (HRQoL).

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Survival time in each group will be compared as well as effect of each treatment arm on cholestasis and HRQoL
timeFrame: 2.4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotteville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Michel Kahaleh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cerecedo-Rodriguez J, Phillips M, Figueroa-Barojas P, Kumer SC, Gaidhane M, Schmitt T, Kahaleh M. Self expandable metal stents for anastomotic stricture following liver transplant. Dig Dis Sci. 2013 Sep;58(9):2661-6. doi: 10.1007/s10620-013-2703-0. Epub 2013 May 24.