S-1 and Photodynamic Therapy in Cholangiocarcinoma

Cholangiocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00869635
• Other study ID #: 2009-0056
• Status: Completed
• Phase: Phase 3
• First received: March 25, 2009
• Last updated: February 5, 2014
• Start date: February 2009
• Est. completion date: August 2013

Study information

• Verified date: February 2014
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cholangiocarcinoma

Intervention

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
• Systemic chemotherapy except S-1
Variable systemic chemotherapy except S-1

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Park do H, Lee SS, Park SE, Lee JL, Choi JH, Choi HJ, Jang JW, Kim HJ, Eum JB, Seo DW, Lee SK, Kim MH, Lee JB. Randomised phase II trial of photodynamic therapy plus oral fluoropyrimidine, S-1, versus photodynamic therapy alone for unresectable hilar chol — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare overall survival time in patients with unresectable perihilar cholangiocarcinoma treated with photodynamic therapy combined with or without S-1		12 months after study start	Yes
Secondary	Compare the frequency of repeat photodynamic therapy		6 months after study start	Yes
Secondary	Compare the frequency of biliary tract decompressive interventions		6 months after study start	Yes
Secondary	Compare the frequency of hospitalization		6 months after study start	Yes