NCT00869635

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2009

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2009

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

February 6, 2014

Status Verified

February 1, 2014

Enrollment Period

4.4 years

First QC Date

March 25, 2009

Last Update Submit

February 5, 2014

Conditions

Cholangiocarcinoma

Keywords

CholangiocarcinomaPhotodynamic therapyS-1

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (3)

1

EXPERIMENTAL

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 ChemotherapyProcedure: Photodynamic therapy

2

ACTIVE COMPARATOR

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

3

OTHER

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

Procedure: Photodynamic therapyProcedure: Systemic chemotherapy except S-1

Interventions

S-1 ChemotherapyDRUG

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

1
Photodynamic therapyPROCEDURE

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

123
Systemic chemotherapy except S-1PROCEDURE

Variable systemic chemotherapy except S-1

3

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Another neoplasia
  • Porphyria
  • Pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (1)

  • Park DH, Lee SS, Park SE, Lee JL, Choi JH, Choi HJ, Jang JW, Kim HJ, Eum JB, Seo DW, Lee SK, Kim MH, Lee JB. Randomised phase II trial of photodynamic therapy plus oral fluoropyrimidine, S-1, versus photodynamic therapy alone for unresectable hilar cholangiocarcinoma. Eur J Cancer. 2014 May;50(7):1259-68. doi: 10.1016/j.ejca.2014.01.008. Epub 2014 Jan 30.

    PMID: 24485665RESULT

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Officials

  • Do Hyun Park, MD, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 25, 2009

First Posted

March 26, 2009

Study Start

February 1, 2009

Primary Completion

July 1, 2013

Study Completion

August 1, 2013

Last Updated

February 6, 2014

Record last verified: 2014-02

Locations

KR(1)