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S-1 and Photodynamic Therapy in Cholangiocarcinoma

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ClinicalTrials.gov Identifier: NCT00869635
Recruitment Status : Completed
First Posted : March 26, 2009
Last Update Posted : February 6, 2014
Sponsor:
Information provided by (Responsible Party):
Do Hyun Park, Asan Medical Center

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.

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

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  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : February 2009
Actual Primary Completion Date : July 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  1. 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 Measures :
  1. Compare the frequency of repeat photodynamic therapy [ Time Frame: 6 months after study start ]
  2. Compare the frequency of biliary tract decompressive interventions [ Time Frame: 6 months after study start ]
  3. Compare the frequency of hospitalization [ Time Frame: 6 months after study start ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Responsible Party: Do Hyun Park, Assistant professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00869635     History of Changes
Other Study ID Numbers: 2009-0056
First Posted: March 26, 2009    Key Record Dates
Last Update Posted: February 6, 2014
Last Verified: February 2014

Keywords provided by Do Hyun Park, Asan Medical Center:
Cholangiocarcinoma
Photodynamic therapy
S-1

Additional relevant MeSH terms:
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Dihematoporphyrin Ether
Antineoplastic Agents
Dermatologic Agents
Photosensitizing Agents