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S-1 and Photodynamic Therapy in Cholangiocarcinoma

NCT00869635 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2014-02-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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

PROCEDURE

Photodynamic therapy

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

PROCEDURE

Systemic chemotherapy except S-1

Variable systemic chemotherapy except S-1

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Do Hyun Park, MD, PhD · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2013-07-31
Completion
2013-08-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00869635 on ClinicalTrials.gov