Photodynamic Therapy (PDT) Trial for Palliation of Cholangiocarcinoma

Phase 3

Terminated

• Conditions: Cholangiocarcinoma
• Interventions: Procedure: ERCP and Photodynamic Therapy; Procedure: ERCP only

• Registration Number: NCT00907413
• Lead Sponsor: Weill Medical College of Cornell University

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).

Study Timeline

• Study First Submitted: 2009-05-21
• Study First Submitted QC: 2009-05-21
• Study First Posted: 2009-05-22
• Study Start: 2010-05
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-01
• Last Update Posted: 2015-06-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERCP and PDT	ERCP and Photodynamic Therapy	Endoscopic Retrograde Cholangio Pancreatography (ERCP) and stenting combined with Photodynamic Dynamic Therapy ERCP and PDT
ERCP alone	ERCP only	Endoscopic Retrograde Cholangio Pancreatography (ERCP) with stenting alone
ERCP and PDT	ERCP only	Endoscopic Retrograde Cholangio Pancreatography (ERCP) and stenting combined with Photodynamic Dynamic Therapy ERCP and PDT

Primary Outcome Measures

Name	Time	Method
Survival time in each group will be compared as well as effect of each treatment arm on cholestasis and HRQoL	2.4 years

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlotteville, Virginia, United States