S-1 and Photodynamic Therapy in Cholangiocarcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2013-08-31

Brief Summary

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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.

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Detailed Description

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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

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Cholangiocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Treatment by combination of photodynamic therapy and S-1

1. PDT with Photofrin® 2mg/kg i.v. 48hrs before laser activation
2. 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

Group Type EXPERIMENTAL

S-1 Chemotherapy

Intervention Type DRUG

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

Photodynamic therapy

Intervention Type PROCEDURE

PDT with Photofrin® 2mg/kg i.v. 48hrs before laser activation

2

Treatment by photodynamic therapy only

1. PDT with Photofrin® 2mg/kg i.v. 48hrs before laser activation
2. Other managements except systemic chemotherapy were added freely.

Group Type ACTIVE_COMPARATOR

Photodynamic therapy

Intervention Type PROCEDURE

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

Group Type OTHER

Photodynamic therapy

Intervention Type PROCEDURE

PDT with Photofrin® 2mg/kg i.v. 48hrs before laser activation

Systemic chemotherapy except S-1

Intervention Type PROCEDURE

Variable systemic chemotherapy except S-1

Interventions

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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

Intervention Type DRUG

Photodynamic therapy

PDT with Photofrin® 2mg/kg i.v. 48hrs before laser activation

Intervention Type PROCEDURE

Systemic chemotherapy except S-1

Variable systemic chemotherapy except S-1

Intervention Type PROCEDURE

Eligibility Criteria

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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