Extrahepatic Bile Duct CancerPhase 3Photostent-02NCT00513539
Biliary Stenting With or Without Photodynamic Therapy in Treating Patients With Locally Advanced, Recurrent, or Metastatic Cholangiocarcinoma or Other Biliary Tract Tumors That Cannot Be Removed by Surgery
A Phase 3 study testing porfimer sodium and biliary stenting in people with Extrahepatic Bile Duct Cancer and Gallbladder Cancer, run by University College, London at 4 sites in United Kingdom.
Trial summary
RATIONALE: Biliary stenting is the placement of a tube in the bile ducts to keep a blocked area open. Photodynamic therapy uses a drug, such as porfimer sodium, that is absorbed by tumor cells. The drug becomes active when it is exposed to light. When the drug is active, tumor cells are killed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extrahepatic Bile Duct Cancer, Gallbladder Cancer
- What is being tested?
- porfimer sodium and biliary stenting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Jul 2007to Dec 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathological/cytological diagnosis of nonresectable locally advanced, recurrent, or metastatic biliary tract carcinoma (intra- or extra-hepatic), or gallbladder carcinoma
- Adequate biliary drainage, with no evidence of active uncontrolled infection (patients on antibiotics are eligible)
- ECOG performance status 0, 1, 2, or 3
- Estimated life expectancy > 3 months
- Women of child-bearing potential should have a negative pregnancy test prior to study entry AND be using an adequate contraception method, which must be continued for 1 month after completion of treatment
- Not pregnant or nursing
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- Patients may have undergone a non-curative operation (i.e., R2 resection [with macroscopic residual disease] or palliative bypass surgery only) and fully recovered
- Patients who have previously undergone curative surgery must have evidence of non-resectable disease relapse
- Patients may have received prior radiotherapy within the past 28 days (with or without radio-sensitizing low-dose chemotherapy) for localized disease and fully recovered
- Must have clear evidence of disease progression prior to inclusion in this study
- Patients may have received prior chemotherapy within the past 28 days and fully recovered
- Must have clear evidence of disease progression prior to inclusion in this study
Who cannot join
- Porphyria
- No brain metastases
- PATIENT CHARACTERISTICS:
- History of prior malignancy that will interfere with the response evaluation (exceptions include in-situ carcinoma of the cervix treated by cone-biopsy/resection, non-metastatic basal and/or squamous cell carcinomas of the skin, or any early stage (stage l) malignancy adequately resected for cure greater than 5 years previously)
- Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial
- Any psychiatric or other disorder likely to impact on informed consent
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- PRIOR CONCURRENT THERAPY:
- Previous treatment with curative intent for current disease in the last 12 weeks (i.e., prior resection, radical radiotherapy, or chemotherapy)
- Previous treatment with experimental therapy for current disease in the last 12 weeks
- No cytotoxic chemotherapy, radiotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids), or experimental medications will be permitted for the first four weeks of the study
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Ninewells Hospital
Dundee, Scotland, DD1 9SY
Aintree University Hospital
Liverpool, England, L9 7AL
University College Hospital
London, England, NW1 2PG
Queen's Medical Centre
Nottingham, England, NG7 2UH
About this study
Official title: Porfimer Sodium Photodynamic Therapy Plus Stenting Versus Stenting Alone in Patients With Advanced or Metastatic Cholangiocarcinomas and Other Biliary Tract Tumours: a Multicentre, Randomised, Phase Lll Study
RATIONALE: Biliary stenting is the placement of a tube in the bile ducts to keep a blocked area open. Photodynamic therapy uses a drug, such as porfimer sodium, that is absorbed by tumor cells. The drug becomes active when it is exposed to light. When the drug is active, tumor cells are killed. It is not yet known whether biliary stenting is more effective with or without photodynamic therapy in treating patients with biliary tract tumors.
PURPOSE: This randomized phase III trial is studying biliary stenting to see how well it works compared with biliary stenting and photodynamic therapy using porfimer sodium in treating patients with locally advanced, recurrent, or metastatic cholangiocarcinoma or other biliary tract tumors that cannot be removed by surgery.
Read the detailed description
OBJECTIVES:
Primary
- To assess the efficacy, in terms of overall survival, of biliary stenting with vs without photodynamic therapy using porfimer sodium in advanced, recurrent, or metastatic biliary tract carcinoma.
Secondary
- To evaluate the two treatments arms with respect to progression-free survival, toxicity using NCI Common Toxicity Criteria (version 3.0), and quality of life.
OUTLINE: This is a multicenter study. Patients are stratified by participating center, primary site (gallbladder vs bile duct), disease stage (locally advanced vs metastatic), prior therapy (i.e., surgery, radiotherapy or chemotherapy) (yes vs no), performance score (0 vs 1 vs 2 vs 3), and prior treatment arm on UK chemotherapy trial ABC-02 (gemcitabine hydrochloride alone vs gemcitabine hydrochloride and cisplatin). Patients are randomized to 1 of 2 arms.
- Arm I: Patients undergo either endoscopic or percutaneous drainage and insertion of unilateral or bilateral plastic endoprostheses above the main strictures of the right and left hepatic bile ducts.
- Arm II: Patients undergo treatment as in arm I. Patients also receive porfimer sodium IV and then undergo laser activation 48 hours later.
After completion of study treatment, patients are followed every 3 months for at least 3 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
- Conditions
- Extrahepatic Bile Duct Cancer, Gallbladder Cancer
- Being tested
- porfimer sodium, biliary stenting
- Keywords
- unresectable gallbladder cancer, recurrent gallbladder cancer, metastatic gallbladder cancer, cholangiocarcinoma of the gallbladder, unresectable extrahepatic bile duct cancer, recurrent extrahepatic bile duct cancer, metastatic extrahepatic bile duct cancer, cholangiocarcinoma of the extrahepatic bile duct
- Medical subject headings
- Bile Duct Neoplasms, Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
porfimer sodiumDrug
biliary stentingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Biliary Stenting alone Receives: Procedure: biliary stenting |
| Arm B | Experimental | Photodynamic Therapy plus biliary stenting Receives: Drug: porfimer sodium; Procedure: biliary stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: minimum follow up 3 years or until death
Secondary outcomes (3)
Progression-free survival every 3 months
Measured: minimum follow up 3 years or until death
Toxicity as assessed by NCI CTC v. 3.0
Measured: patients followed up for minimum of 3 years
Quality of life as assessed by EORTC QLQ 30 and PAN 26 at baseline and 1, 3, and 6 months after completion of study treatment
Measured: patients followed up for a minimum of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extrahepatic Bile Duct CancerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen P. Pereira, MD, Study chair, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00513539
- Sponsor's protocol ID
- CDR0000558540
- Other IDs
- CRUK-PHOTOSTENT-02, EU-20740, EUDRACT-2005-001173-96, ISRCTN87712758, CTA-20363/0207/001-0001
- Acronym
- Photostent-02
- Status last verified
- Feb 2013
- First submitted
- 6 Aug 2007
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Porfimer Sodium Photodynamic Therapy Plus Stenting Versus Stenting Alone in Patients With Advanced or Metastatic Cholangiocarcinomas and Other Biliary Tract Tumours: a Multicentre, Randomised, Phase Lll Study
- ClinicalTrials.gov ID
- NCT00513539
- Acronym / sponsor ID
- Photostent-02 / CDR0000558540
- Conditions
- Extrahepatic Bile Duct Cancer, Gallbladder Cancer
- Keywords
- unresectable gallbladder cancer, recurrent gallbladder cancer, metastatic gallbladder cancer, cholangiocarcinoma of the gallbladder, unresectable extrahepatic bile duct cancer, recurrent extrahepatic bile duct cancer, metastatic extrahepatic bile duct cancer, cholangiocarcinoma of the extrahepatic bile duct
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Dec 2009 (actual)
- First posted
- 8 Aug 2007 (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.
RATIONALE: Biliary stenting is the placement of a tube in the bile ducts to keep a blocked area open. Photodynamic therapy uses a drug, such as porfimer sodium, that is absorbed by tumor cells. The drug becomes active when it is exposed to light. When the drug is active, tumor cells are killed. It is not yet known whether biliary stenting is more effective with or without photodynamic therapy in treating patients with biliary tract tumors.
PURPOSE: This randomized phase III trial is studying biliary stenting to see how well it works compared with biliary stenting and photodynamic therapy using porfimer sodium in treating patients with locally advanced, recurrent, or metastatic cholangiocarcinoma or other biliary tract tumors that cannot be removed by surgery.
Detailed description
OBJECTIVES:
Primary
- To assess the efficacy, in terms of overall survival, of biliary stenting with vs without photodynamic therapy using porfimer sodium in advanced, recurrent, or metastatic biliary tract carcinoma.
Secondary
- To evaluate the two treatments arms with respect to progression-free survival, toxicity using NCI Common Toxicity Criteria (version 3.0), and quality of life.
OUTLINE: This is a multicenter study. Patients are stratified by participating center, primary site (gallbladder vs bile duct), disease stage (locally advanced vs metastatic), prior therapy (i.e., surgery, radiotherapy or chemotherapy) (yes vs no), performance score (0 vs 1 vs 2 vs 3), and prior treatment arm on UK chemotherapy trial ABC-02 (gemcitabine hydrochloride alone vs gemcitabine hydrochloride and cisplatin). Patients are randomized to 1 of 2 arms.
- Arm I: Patients undergo either endoscopic or percutaneous drainage and insertion of unilateral or bilateral plastic endoprostheses above the main strictures of the right and left hepatic bile ducts.
- Arm II: Patients undergo treatment as in arm I. Patients also receive porfimer sodium IV and then undergo laser activation 48 hours later.
After completion of study treatment, patients are followed every 3 months for at least 3 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Procedure: biliary stentingBiliary Stenting alone |
| Arm B | Experimental | Drug: porfimer sodium, Procedure: biliary stentingPhotodynamic Therapy plus biliary stenting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histopathological/cytological diagnosis of nonresectable locally advanced, recurrent, or metastatic biliary tract carcinoma (intra- or extra-hepatic), or gallbladder carcinoma
- Adequate biliary drainage, with no evidence of active uncontrolled infection (patients on antibiotics are eligible)
- ECOG performance status 0, 1, 2, or 3
- Estimated life expectancy > 3 months
- Women of child-bearing potential should have a negative pregnancy test prior to study entry AND be using an adequate contraception method, which must be continued for 1 month after completion of treatment
Key exclusion criteria (10 listed)
- Porphyria
- No brain metastases
- History of prior malignancy that will interfere with the response evaluation (exceptions include in-situ carcinoma of the cervix treated by cone-biopsy/resection, non-metastatic basal and/or squamous cell carcinomas of the skin, or any early stage (stage l) malignancy adequately resected for cure greater than 5 years previously)
- Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial
- Any psychiatric or other disorder likely to impact on informed consent
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 |
|---|---|---|
| porfimer sodium | Drug | Arm B |
| biliary stenting | Procedure or surgery | Arm A, Arm B |
Primary outcome
Overall survival
Time frame: minimum follow up 3 years or until death
3 secondary outcomes
Progression-free survival every 3 months
Time frame: minimum follow up 3 years or until death
Toxicity as assessed by NCI CTC v. 3.0
Time frame: patients followed up for minimum of 3 years
Quality of life as assessed by EORTC QLQ 30 and PAN 26 at baseline and 1, 3, and 6 months after completion of study treatment
Time frame: patients followed up for a minimum of 3 years
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 20 Feb 2013.
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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.
Stephen P. Pereira, MD study chair
University College London Hospitals
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing porfimer sodium and biliary stenting in people with Extrahepatic Bile Duct Cancer and Gallbladder Cancer, run by University College, London at 4 sites in United Kingdom.
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 12 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: finished, as of the sponsor's last update on 20 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. 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?
Overall survival (time frame: minimum follow up 3 years or until death). 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 20 Feb 2013.