CholangiocarcinomaPhase 3NCT00869635
S-1 and Photodynamic Therapy in Cholangiocarcinoma
A Phase 3 study testing S-1 Chemotherapy, Photodynamic therapy and Systemic chemotherapy except S-1 in people with Cholangiocarcinoma, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- S-1 Chemotherapy, Photodynamic therapy and Systemic chemotherapy except S-1
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2009to Aug 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Another neoplasia
- Porphyria
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cholangiocarcinoma
- Being tested
- S-1 Chemotherapy, Photodynamic therapy, Systemic chemotherapy except S-1
- Keywords
- Cholangiocarcinoma, Photodynamic therapy, S-1
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Photodynamic therapyProcedure or surgery
PDT with Photofrin® 2mg/kg i.v. 48hrs before laser activation
Systemic chemotherapy except S-1Procedure or surgery
Variable systemic chemotherapy except S-1
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: S-1 Chemotherapy; Procedure: 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. Receives: Procedure: Photodynamic therapy |
| 3 | Other | Treatment by photodynamic therapy only or combined chemotherapy with photodynamic therapy: Open label Receives: Procedure: Photodynamic therapy; Procedure: Systemic chemotherapy except S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare overall survival time in patients with unresectable perihilar cholangiocarcinoma treated with photodynamic therapy combined with or without S-1
Measured: 12 months after study start
Secondary outcomes (3)
Compare the frequency of repeat photodynamic therapy
Measured: 6 months after study start
Compare the frequency of biliary tract decompressive interventions
Measured: 6 months after study start
Compare the frequency of hospitalization
Measured: 6 months after study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Do Hyun Park, Asan Medical Center
- Investigators
- Do Hyun Park, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869635
- Sponsor's protocol ID
- 2009-0056
- Status last verified
- Feb 2014
- First submitted
- 25 Mar 2009
- Last updated
- 6 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24485665
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00869635
- Acronym / sponsor ID
- 2009-0056
- Conditions
- Cholangiocarcinoma
- Keywords
- Cholangiocarcinoma, Photodynamic therapy, S-1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 26 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: S-1 Chemotherapy, Procedure: Photodynamic therapyTreatment 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 |
| 2 | Active comparator | Procedure: Photodynamic therapyTreatment 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. |
| 3 | Other | Procedure: Photodynamic therapy, Procedure: Systemic chemotherapy except S-1Treatment by photodynamic therapy only or combined chemotherapy with photodynamic therapy: Open label |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- Another neoplasia
- Porphyria
- Pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-1 ChemotherapyS-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 | 1 |
| Photodynamic therapyPDT with Photofrin® 2mg/kg i.v. 48hrs before laser activation | Procedure or surgery | 1, 2, 3 |
| Systemic chemotherapy except S-1Variable systemic chemotherapy except S-1 | Procedure or surgery | 3 |
Primary outcome
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
3 secondary outcomes
Compare the frequency of repeat photodynamic therapy
Time frame: 6 months after study start
Compare the frequency of biliary tract decompressive interventions
Time frame: 6 months after study start
Compare the frequency of hospitalization
Time frame: 6 months after study start
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2014.
- Results publication: PubMed 24485665Park 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Do Hyun Park, MD, PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing S-1 Chemotherapy, Photodynamic therapy and Systemic chemotherapy except S-1 in people with Cholangiocarcinoma, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00869635, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2014.