S-1 and Photodynamic Therapy in Cholangiocarcinoma

Study Overview
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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.

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.

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

Conditions
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Cholangiocarcinoma

Intervention / Treatment
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* Drug: S-1 Chemotherapy
* Procedure: Photodynamic therapy
* Procedure: Systemic chemotherapy except S-1


Participation Criteria
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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 Exclusion Criteria: Another neoplasia Porphyria Pregnant or breastfeeding women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* 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<br>Procedure: Photodynamic therapy<br>* PDT with Photofrin® 2mg/kg i.v. 48hrs before laser activation<br>|
| Active Comparator: 2<br>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<br>* PDT with Photofrin® 2mg/kg i.v. 48hrs before laser activation<br>|
| Other: 3<br>Treatment by photodynamic therapy only or combined chemotherapy with photodynamic therapy: Open label | Procedure: Photodynamic therapy<br>* PDT with Photofrin® 2mg/kg i.v. 48hrs before laser activation<br>Procedure: Systemic chemotherapy except S-1<br>* Variable systemic chemotherapy except S-1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholangiocarcinoma, Photodynamic therapy, S-1