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


Phase 3
18 Years
N/A
Not Enrolling
Both
Cholangiocarcinoma

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Trial Information

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


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).


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

2.4 years

Safety Issue:

Yes

Principal Investigator

Michel Kahaleh, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia

Authority:

United States: Institutional Review Board

Study ID:

13898

NCT ID:

NCT00907413

Start Date:

May 2010

Completion Date:

June 2011

Related Keywords:

  • Cholangiocarcinoma
  • cancer
  • bile duct
  • Cholangiocarcinoma

Name

Location

University of VirginiaCharlottesville, Virginia  22908