S-1 and Photodynamic Therapy in Cholangiocarcinoma

February 5, 2014 updated by: Do Hyun Park, Asan Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1

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
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
Active Comparator: 2

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.
Procedure: Photodynamic therapy
PDT with Photofrin® 2mg/kg i.v. 48hrs before laser activation
Other: 3
Treatment by photodynamic therapy only or combined chemotherapy with photodynamic therapy: Open label
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare overall survival time in patients with unresectable perihilar cholangiocarcinoma treated with photodynamic therapy combined with or without S-1
Time Frame: 12 months after study start
12 months after study start

Secondary Outcome Measures

Outcome Measure
Time Frame
Compare the frequency of repeat photodynamic therapy
Time Frame: 6 months after study start
6 months after study start
Compare the frequency of biliary tract decompressive interventions
Time Frame: 6 months after study start
6 months after study start
Compare the frequency of hospitalization
Time Frame: 6 months after study start
6 months after study start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Do Hyun Park, MD, PhD, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

March 25, 2009

First Submitted That Met QC Criteria

March 25, 2009

First Posted (Estimate)

March 26, 2009

Study Record Updates

Last Update Posted (Estimate)

February 6, 2014

Last Update Submitted That Met QC Criteria

February 5, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-0056

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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