Non-curative Resectable Bile Duct CarcinomaPhase 2NCT01016002
Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma
A Phase 2 study testing Temoporfin in people with Non-curative Resectable Bile Duct Carcinoma, run by University of Salzburg at 2 sites in 2 countries.
Trial summary
The purpose of this study is to assess efficacy and safety of Foscan (temoporfin) photodynamic therapy in the treatment of locally advanced perihilar bile duct carcinoma without distant metastases. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Non-curative Resectable Bile Duct Carcinoma
- What is being tested?
- Temoporfin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2006to Dec 2011
- Phase
- Phase 2
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- bile duct carcinoma proven by histology in advanced or non-operable stage or tumor extension:
- Bismuth type III or IV ( not resectable with R0-margins )
- Bismuth type I or II, if resective surgery is contraindicated for old age or poor surgical risk of patient
- sufficient general condition to undergo PDT (Karnofsky status > 30%)
- age > 19 years
- access to common bile duct (either via endoscopy after sphincterotomy or percutaneously after transhepatic drainage),
- informed written consent
Who cannot join
- porphyria or other diseases exacerbated by light
- known intolerance or allergies to porphyrin derivatives
- a planned surgical procedure within the next 30 days
- coexisting ophthalmic disease likely to require slit lamp examination within the next 30 days
- impaired kidney or liver function (creatinine > 2.5x elevated, INR > 2.2 on vitamin K),
- leukopenia ( WBC < 2000/cmm ) or thrombopenia ( < 50000/cmm ),
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- cytotoxic chemotherapy within the past 4 weeks.
- pregnancy ( and safe contraception for 6 months after PDT )
- accompanying/complicating disease with very poor prognosis (expected survival < 6 weeks),
- proven advanced peritoneal carcinomatosis ( PET scan imaging, ascites positive for tumor cells)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Austria1 site, 1 recruiting
- Recruiting
Department of Internal Medicine I, Paracelsus Medical University Salzburg
Salzburg, State of Salzburg, 5020
Frieder Berr, Prof., MD, f.berr@salk.at
Frieder Berr, Prof., MD
Germany1 site, 1 recruiting
- Recruiting
Internal Medicine Dept., University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246
A. Lohse, Prof., MD, alohse@uke-uni-hamburg.de
A. Lohse, Prof., MD
About this study
Official title: A Phase II, Open-label, Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma
The purpose of this study is to assess efficacy and safety of Foscan (temoporfin) photodynamic therapy in the treatment of locally advanced perihilar bile duct carcinoma without distant metastases.
- Being tested
- Temoporfin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemoporfinDrug
Also called Foscan, Meso-tetrahydroxyphenyl Chlorin
Drug treatment: Temoporfin 0.15 mg/kg body weight, intravenous injection within at least 6 min.
Laser Treatment: 652nm wavelength; 30 Joules/cm diffusor length ( 200 sec at 150mW/cm diffusor length), within 96 h after Foscan
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Drug: Temoporfin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of local response and depth of tumoricidal tissue penetration of Foscan-PDT
Measured: post treatment
Secondary outcomes (2)
Progression-free survival time, overall survival time
Measured: Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention
Toxicity using WHO criteria and criteria for local toxicity in the biliary system
Measured: Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startJan 2006
- Primary completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-curative Resectable Bile Duct CarcinomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salzburg
- Sponsor type
- University, hospital or other
- Collaborators
- Biolitec Pharma Ltd.
- Investigators
- Frieder Berr, Prof., MD, Principal investigator, Department of Internal Medicine I, Paracelsus Medical University Salzburg, Muellner Hauptstrasse 48, 5020, Salzburg, AustriaLohse A, Prof., MD, Principal investigator, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016002
- Sponsor's protocol ID
- Foscan 1/2005
- Other IDs
- EUDRA CT 2005-004866-17
- Status last verified
- Nov 2009
- First submitted
- 16 Nov 2009
- Last updated
- 18 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-label, Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma
- ClinicalTrials.gov ID
- NCT01016002
- Acronym / sponsor ID
- Foscan 1/2005
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of SalzburgUniversity, hospital or other
- Collaborators
- Biolitec Pharma Ltd.
- Study start
- Jan 2006
- Primary completion
- Dec 2011 (estimated)
- First posted
- 18 Nov 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.
The purpose of this study is to assess efficacy and safety of Foscan (temoporfin) photodynamic therapy in the treatment of locally advanced perihilar bile duct carcinoma without distant metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Temoporfin |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- bile duct carcinoma proven by histology in advanced or non-operable stage or tumor extension:
- sufficient general condition to undergo PDT (Karnofsky status > 30%)
- age > 19 years
- access to common bile duct (either via endoscopy after sphincterotomy or percutaneously after transhepatic drainage),
- informed written consent
Key exclusion criteria (10 listed)
- porphyria or other diseases exacerbated by light
- known intolerance or allergies to porphyrin derivatives
- a planned surgical procedure within the next 30 days
- coexisting ophthalmic disease likely to require slit lamp examination within the next 30 days
- impaired kidney or liver function (creatinine > 2.5x elevated, INR > 2.2 on vitamin K),
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 |
|---|---|---|
| TemoporfinAlso: Foscan, Meso-tetrahydroxyphenyl ChlorinDrug treatment: Temoporfin 0.15 mg/kg body weight, intravenous injection within at least 6 min. Laser Treatment: 652nm wavelength; 30 Joules/cm diffusor length ( 200 sec at 150mW/cm diffusor length), within 96 h after Foscan | Drug | Intervention |
Primary outcome
Rate of local response and depth of tumoricidal tissue penetration of Foscan-PDT
Time frame: post treatment
2 secondary outcomes
Progression-free survival time, overall survival time
Time frame: Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention
Toxicity using WHO criteria and criteria for local toxicity in the biliary system
Time frame: Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2009.
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.
Frieder Berr, Prof., MD principal investigator
Department of Internal Medicine I, Paracelsus Medical University Salzburg, Muellner Hauptstrasse 48, 5020, Salzburg, Austria
Lohse A, Prof., MD principal investigator
University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Temoporfin in people with Non-curative Resectable Bile Duct Carcinoma, run by University of Salzburg at 2 sites in 2 countries.
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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 18 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frieder Berr, Prof., MD ((43-) 662-4482 ext. 2800, f.berr@salk.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of local response and depth of tumoricidal tissue penetration of Foscan-PDT (time frame: post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2009.