S-1 and Photodynamic Therapy in Cholangiocarcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Do Hyun Park, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00869635
First received: March 25, 2009
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Cholangiocarcinoma
Drug: S-1 Chemotherapy
Procedure: Photodynamic therapy
Procedure: Systemic chemotherapy except S-1
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Photodynamic Therapy With S-1 in the Patients With Unresectable Type III or IV Cholangiocarcinoma: A Prospective Randomized Trial With Open Label Control

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Compare the frequency of repeat photodynamic therapy [ Time Frame: 6 months after study start ] [ Designated as safety issue: Yes ]
  • Compare the frequency of biliary tract decompressive interventions [ Time Frame: 6 months after study start ] [ Designated as safety issue: Yes ]
  • Compare the frequency of hospitalization [ Time Frame: 6 months after study start ] [ Designated as safety issue: Yes ]

Enrollment: 43
Study Start Date: February 2009
Study Completion Date: August 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869635

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Do Hyun Park, MD, PhD Asan Medical Center
  More Information

Publications:
Responsible Party: Do Hyun Park, Assistant professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00869635     History of Changes
Other Study ID Numbers: 2009-0056
Study First Received: March 25, 2009
Last Updated: February 5, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
Cholangiocarcinoma
Photodynamic therapy
S-1

Additional relevant MeSH terms:
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on September 11, 2014