S-1 and Photodynamic Therapy in Cholangiocarcinoma

Sponsor

Asan Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00869635

Collaborator

(none)

Enrollment

Location

Arms

53.9

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

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

Detailed Description

Study Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

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

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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
Other: 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

Arm

Intervention/Treatment

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

Other: 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

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul		Korea, Republic of	138-736

Sponsors and Collaborators

Asan Medical Center

Investigators

Principal Investigator: Do Hyun Park, MD, PhD, Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Do Hyun Park, Assistant professor, Asan Medical Center

ClinicalTrials.gov Identifier:

NCT00869635

Other Study ID Numbers:

2009-0056

First Posted:

Mar 26, 2009

Last Update Posted:

Feb 6, 2014

Last Verified:

Feb 1, 2014

Keywords provided by Do Hyun Park, Assistant professor, Asan Medical Center

Cholangiocarcinoma

Photodynamic therapy

S-1

Additional relevant MeSH terms:

Cholangiocarcinoma

Study Results

No Results Posted as of Feb 6, 2014