NCT00869635

S-1 and Photodynamic Therapy in Cholangiocarcinoma

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	S-1 Chemotherapy	S-1 chemotherapy before intolerable complication or definite tumor progression Based on the body surface area, \<1.25m2: 80mg/day, 1.25\~1.5m2: 100mg/day, ≧1.5m2: 120mg/day Given orally twice daily for 14days, followed by 7 days without treatment
PROCEDURE	Photodynamic therapy	PDT with Photofrin® 2mg/kg i.v. 48hrs before laser activation
PROCEDURE	Systemic chemotherapy except S-1	Variable systemic chemotherapy except S-1

Timeline

• Start date: 2009-02-01
• Primary completion: 2013-07-01
• Completion: 2013-08-01
• First posted: 2009-03-26
• Last updated: 2014-02-06

Locations

1 site across 1 country: South Korea