S-1 and Photodynamic Therapy in Cholangiocarcinoma
- Conditions
- Cholangiocarcinoma
- Interventions
- Registration Number
- NCT00869635
- Lead Sponsor
- Asan Medical Center
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
- 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
- Another neoplasia
- Porphyria
- Pregnant or breastfeeding women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Photodynamic therapy 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 2 Photodynamic therapy 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. 3 Photodynamic therapy Treatment by photodynamic therapy only or combined chemotherapy with photodynamic therapy: Open label 3 Systemic chemotherapy except S-1 Treatment by photodynamic therapy only or combined chemotherapy with photodynamic therapy: Open label 1 S-1 Chemotherapy 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
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Asan Medical Center🇰🇷Seoul, Korea, Republic of