Back to resultsS-1 and Photodynamic Therapy in Cholangiocarcinoma
Primary Purpose
Cholangiocarcinoma
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
S-1 Chemotherapy
Photodynamic therapy
Systemic chemotherapy except S-1
Sponsored by
About this trial
This is an interventional treatment trial for Cholangiocarcinoma focused on measuring Cholangiocarcinoma, Photodynamic therapy, S-1
Eligibility 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
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
1
2
3
Arm Description
Treatment by combination of photodynamic therapy and S-1 PDT with Photofrin® 2mg/kg i.v. 48hrs before laser activation 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
Treatment by photodynamic therapy only PDT with Photofrin® 2mg/kg i.v. 48hrs before laser activation Other managements except systemic chemotherapy were added freely.
Treatment by photodynamic therapy only or combined chemotherapy with photodynamic therapy: Open label
Outcomes
Primary Outcome Measures
Compare overall survival time in patients with unresectable perihilar cholangiocarcinoma treated with photodynamic therapy combined with or without S-1
Secondary Outcome Measures
Compare the frequency of repeat photodynamic therapy
Compare the frequency of biliary tract decompressive interventions
Compare the frequency of hospitalization
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00869635
Brief Title
S-1 and Photodynamic Therapy in Cholangiocarcinoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiocarcinoma
Keywords
Cholangiocarcinoma, Photodynamic therapy, S-1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Treatment by combination of photodynamic therapy and S-1
PDT with Photofrin® 2mg/kg i.v. 48hrs before laser activation
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
Arm Title
2
Arm Type
Active Comparator
Arm Description
Treatment by photodynamic therapy only
PDT with Photofrin® 2mg/kg i.v. 48hrs before laser activation
Other managements except systemic chemotherapy were added freely.
Arm Title
3
Arm Type
Other
Arm Description
Treatment by photodynamic therapy only or combined chemotherapy with photodynamic therapy: Open label
Intervention Type
Drug
Intervention Name(s)
S-1 Chemotherapy
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Photodynamic therapy
Intervention Description
PDT with Photofrin® 2mg/kg i.v. 48hrs before laser activation
Intervention Type
Procedure
Intervention Name(s)
Systemic chemotherapy except S-1
Intervention Description
Variable systemic chemotherapy except S-1
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Compare the frequency of repeat photodynamic therapy
Time Frame
6 months after study start
Title
Compare the frequency of biliary tract decompressive interventions
Time Frame
6 months after study start
Title
Compare the frequency of hospitalization
Time Frame
6 months after study start
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Do Hyun Park, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
24485665
Citation
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.
Results Reference
result
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S-1 and Photodynamic Therapy in Cholangiocarcinoma
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