Photodynamic Therapy (PDT) Trial for Palliation of Cholangiocarcinoma

This study has been terminated.
(PI relocated and reopened trial in new university)
Sponsor:
Information provided by (Responsible Party):
Michel Kahaleh, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00907413
First received: May 21, 2009
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

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).


Condition Intervention Phase
Cholangiocarcinoma
Procedure: ERCP and Photodynamic Therapy
Procedure: ERCP only
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Photodynamic Therapy for Palliation of Unresectable Cholangiocarcinoma A Multicenter, Open Label, Randomized, Controlled Phase III Trial

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Survival time in each group will be compared as well as effect of each treatment arm on cholestasis and HRQoL [ Time Frame: 2.4 years ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: May 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ERCP and PDT
Endoscopic Retrograde Cholangio Pancreatography (ERCP) and stenting combined with Photodynamic Dynamic Therapy ERCP and PDT
Procedure: ERCP and Photodynamic Therapy
Photodynamic Therapy is a new therapeutic approach that specifically targets neoplastic cells. This therapy has been used in other tumors as a local treatment and involves the intravenous administration of a photosensitizing agent followed by activation of the agent by illumination with non-thermal light of a specific wavelength, resulting in cell death from direct cytotoxicity and ischemic necrosis. Cytotoxicity is directly proportional to tissue oxygenation.
Procedure: ERCP only
Endoscopic retrograde cholangiopancreatography and stenting.
Active Comparator: ERCP alone
Endoscopic Retrograde Cholangio Pancreatography (ERCP) with stenting alone
Procedure: ERCP only
Endoscopic retrograde cholangiopancreatography and stenting.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00907413

Locations
United States, Virginia
University of Virginia
Charlotteville, Virginia, United States, 22908
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Michel Kahaleh, MD University of Virginia
  More Information

No publications provided by Weill Medical College of Cornell University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michel Kahaleh, Chief of Endoscopy, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00907413     History of Changes
Other Study ID Numbers: 13898
Study First Received: May 21, 2009
Last Updated: December 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
cancer
bile duct

Additional relevant MeSH terms:
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on October 22, 2014