S-1 and Photodynamic Therapy in Cholangiocarcinoma

Asan Medical Center

Status and phase: Completed; Phase 3

Conditions: Cholangiocarcinoma

Treatments: Procedure: Photodynamic therapy; Procedure: Systemic chemotherapy except S-1; Drug: S-1 Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00869635

2009-0056

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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43 participants in 3 patient groups

1

Experimental group

Description:

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

Treatment:

Drug: S-1 Chemotherapy

Procedure: Photodynamic therapy

2

Active Comparator group

Description:

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.

Treatment:

Procedure: Photodynamic therapy

3

Other group

Description:

Treatment by photodynamic therapy only or combined chemotherapy with photodynamic therapy: Open label

Treatment:

Procedure: Photodynamic therapy

Procedure: Systemic chemotherapy except S-1