Cholangiocarcinoma
Conditions
Keywords
Cholangiocarcinoma, Photodynamic therapy, S-1
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.
Interventions
DRUGS-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
PROCEDUREPhotodynamic therapy
PDT with Photofrin® 2mg/kg i.v. 48hrs before laser activation
PROCEDURESystemic chemotherapy except S-1
Variable systemic chemotherapy except S-1
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
South Korea
Outcome results
None listed