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Photodynamic Therapy (PDT) Trial for Palliation of Cholangiocarcinoma (PDT)

Primary Purpose

Cholangiocarcinoma

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

ERCP and Photodynamic Therapy

ERCP only

About this trial

This is an interventional treatment trial for Cholangiocarcinoma focused on measuring cancer, bile duct

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ERCP and PDT

ERCP alone

Arm Description

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

Endoscopic Retrograde Cholangio Pancreatography (ERCP) with stenting alone

Outcomes

Primary Outcome Measures

Survival time in each group will be compared as well as effect of each treatment arm on cholestasis and HRQoL

Secondary Outcome Measures

Full Information

NCT ID

NCT00907413

First Posted

May 21, 2009

Last Updated

June 1, 2015

Sponsor

Weill Medical College of Cornell University

1. Study Identification

Unique Protocol Identification Number

NCT00907413

Brief Title

Photodynamic Therapy (PDT) Trial for Palliation of Cholangiocarcinoma

Acronym

PDT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Terminated

Why Stopped

PI relocated and reopened trial in new university

Study Start Date

May 2010 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Weill Medical College of Cornell University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cholangiocarcinoma

Keywords

cancer, bile duct

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ERCP and PDT

Arm Type

Experimental

Arm Description

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

Arm Title

ERCP alone

Arm Type

Active Comparator

Arm Description

Endoscopic Retrograde Cholangio Pancreatography (ERCP) with stenting alone

Intervention Type

Procedure

Intervention Name(s)

ERCP and Photodynamic Therapy

Intervention Description

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

Intervention Name(s)

ERCP only

Intervention Description

Endoscopic retrograde cholangiopancreatography and stenting.

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michel Kahaleh, MD

Organizational Affiliation

University of Virginia

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Virginia

City

Charlotteville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23703448

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.

Results Reference

derived

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Photodynamic Therapy (PDT) Trial for Palliation of Cholangiocarcinoma

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