Clinical Trial: S-1 and Photodynamic Therapy in Cholangiocarcinoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Asan Medical Center

Current Primary Outcome: Compare overall survival time in patients with unresectable perihilar cholangiocarcinoma treated with photodynamic therapy combined with or without S-1 [ Time Frame: 12 months after study start ]

Original Primary Outcome: Compare overall survival time in patients with unresectable type Ⅲ or Ⅳ cholangiocarcinoma treated with photodynamic therapy combined with or without S-1 [ Time Frame: 12 months after study start ]

Current Secondary Outcome:

  • Compare the frequency of repeat photodynamic therapy [ Time Frame: 6 months after study start ]
  • Compare the frequency of biliary tract decompressive interventions [ Time Frame: 6 months after study start ]
  • Compare the frequency of hospitalization [ Time Frame: 6 months after study start ]


Original Secondary Outcome: Same as current

Information By: Asan Medical Center

Dates:
Date Received: March 25, 2009
Date Started: February 2009
Date Completion:
Last Updated: February 5, 2014
Last Verified: February 2014