S-1 and Photodynamic Therapy in Cholangiocarcinoma - Full Text View

Purpose

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.

Condition	Intervention	Phase
Cholangiocarcinoma	Drug: S-1 Chemotherapy Procedure: Photodynamic therapy Procedure: Systemic chemotherapy except S-1	Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Compare the frequency of repeat photodynamic therapy [ Time Frame: 6 months after study start ] [ Designated as safety issue: Yes ]
Compare the frequency of biliary tract decompressive interventions [ Time Frame: 6 months after study start ] [ Designated as safety issue: Yes ]
Compare the frequency of hospitalization [ Time Frame: 6 months after study start ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	45
Study Start Date:	February 2009
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Treatment by combination of photodynamic therapy and S-1 PDT with Photofrin® 2mg/kg i.v. 48hrs before laser activation 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	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
Active Comparator: 2 Treatment by photodynamic therapy only PDT with Photofrin® 2mg/kg i.v. 48hrs before laser activation Other managements except systemic chemotherapy were added freely.	Procedure: Photodynamic therapy PDT with Photofrin® 2mg/kg i.v. 48hrs before laser activation
3 Treatment by photodynamic therapy only or combined chemotherapy with photodynamic therapy: Open label	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

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.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869635

Contacts

Contact: Do H Park, Prof. Dr.	82-2-3010-3194	dhpark@amc.seoul.kr
Contact: Jun B Eum, Fellow Dr	82-2-3010-3972	mediperiment@gmail.com

Locations

Korea, Republic of
Asan Medical Center	Recruiting
Seoul, Korea, Republic of, 138-736
Contact 82-2-1688-7575 webmaster@amc.seoul.kr
Sub-Investigator: Jun B Eum, Fellow Dr.
Principal Investigator: Do H Park, Prof. Dr.

Sponsors and Collaborators

Asan Medical Center

Investigators

Principal Investigator:

Do Hyun Park, MD, PhD

Asan Medical Center

More Information

No publications provided

Responsible Party:	Do Hyun Park, Assistant professor, Asan Medical Center
ClinicalTrials.gov Identifier:	NCT00869635 History of Changes
Other Study ID Numbers:	2009-0056
Study First Received:	March 25, 2009
Last Updated:	March 10, 2013
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:

Cholangiocarcinoma
Photodynamic therapy
S-1

Additional relevant MeSH terms:

Cholangiocarcinoma
Adenocarcinoma
Carcinoma

Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on June 13, 2013