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Photodynamic Therapy With S-1 in the Patients With Unresectable Type III or IV Cholangiocarcinoma: A Prospective Randomized Trial With Open Label Control


Phase 3
18 Years
90 Years
Open (Enrolling)
Both
Cholangiocarcinoma

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Trial Information

Photodynamic Therapy With S-1 in the Patients With Unresectable Type III or IV Cholangiocarcinoma: A Prospective Randomized Trial With Open Label Control


In patients with unresectable perihilar cholangiocarcinoma, photodynamic therapy with
biliary stent has been known for palliation of jaundice and improving survival. But most of
therapeutic effects were expected to delay bile duct obstruction rather than to decrease the
tumor. Recently orally available chemotherapeutic agent, S-1 was reported as effective in
patients with bile duct adenocarcinoma. The investigators' aims of study evaluate the
combined effect of photodynamic therapy and S-1.


Inclusion Criteria:



- Histologic or cytologic diagnosis of cholangiocarcinoma

- Not eligible for curative surgery

- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or better

- No serious or uncontrolled concomitant medical illness

- Adequate bone marrow function (absolute neutrophil count ≧1,500 ul, platelet count
≧75,000/ul)

- Consent this study in letter

Exclusion Criteria:

- Another neoplasia

- Porphyria

- Pregnant or breastfeeding women

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Compare overall survival time in patients with unresectable perihilar cholangiocarcinoma treated with photodynamic therapy combined with or without S-1

Outcome Time Frame:

12 months after study start

Safety Issue:

Yes

Principal Investigator

Do Hyun Park, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center

Authority:

Korea: Food and Drug Administration

Study ID:

2009-0056

NCT ID:

NCT00869635

Start Date:

February 2009

Completion Date:

August 2013

Related Keywords:

  • Cholangiocarcinoma
  • Cholangiocarcinoma
  • Photodynamic therapy
  • S-1
  • Cholangiocarcinoma

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