Photodynamic Therapy (PDT) Trial for Palliation of Cholangiocarcinoma

NCT ID: NCT00907413

Last Updated: 2015-06-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-06-30

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).

Conditions

Cholangiocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ERCP and PDT

Endoscopic Retrograde Cholangio Pancreatography (ERCP) and stenting combined with Photodynamic Dynamic Therapy ERCP and PDT

Group Type: EXPERIMENTAL

ERCP and Photodynamic Therapy

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

Endoscopic retrograde cholangiopancreatography and stenting.

ERCP alone

Endoscopic Retrograde Cholangio Pancreatography (ERCP) with stenting alone

Group Type: ACTIVE_COMPARATOR

ERCP only

Intervention Type: PROCEDURE

Endoscopic retrograde cholangiopancreatography and stenting.

Interventions

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.

Intervention Type: PROCEDURE

ERCP only

Endoscopic retrograde cholangiopancreatography and stenting.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Michel Kahaleh

Chief of Endoscopy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michel Kahaleh, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia

Charlotteville, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23703448 (View on PubMed)

Other Identifiers

13898

Identifier Type: -

Identifier Source: org_study_id