Photodynamic Therapy (PDT) Trial for Palliation of Cholangiocarcinoma

Cholangiocarcinoma Clinical Trial

— PDT  

Official title:

Photodynamic Therapy for Palliation of Unresectable Cholangiocarcinoma A Multicenter, Open Label, Randomized, Controlled Phase III Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00907413
• Other study ID #: 13898
• Status: Terminated
• Phase: Phase 3
• First received: May 21, 2009
• Last updated: June 1, 2015
• Start date: May 2010
• Est. completion date: June 2011

Study information

• Verified date: June 2015
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholangiocarcinoma

Intervention

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.
• ERCP only
Endoscopic retrograde cholangiopancreatography and stenting.

Locations

Country	Name	City	State
United States	University of Virginia	Charlotteville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival time in each group will be compared as well as effect of each treatment arm on cholestasis and HRQoL		2.4 years	Yes