CholangiocarcinomaPhase 3CK/PDTNCT00540735
Efficiency Evaluation of Photodynamic Therapy With Photofrin® on Unresectable Type III or IV Cholangiocarcinomas
A Phase 3 study testing photodynamic therapy in people with Cholangiocarcinoma, run by University Hospital, Angers at 18 sites in France.
Trial summary
Unresectable type III or IV cholangiocarcinoma has a very bad prognosis; survival median ranges between 6 and 9 months. Survival depends on biliary drainage quality, obtained by plastic or metallic prothesis setting up in one or several hepatic segments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- photodynamic therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 18 sitesFrance
- Study dates
- Apr 2008to Nov 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
- Obtention of a written informed consent.
- Patient over 18.
- Patient with a type III or IV (according to Bismuth classification) histologically proved cholangiocarcinoma ; histologic diagnosis must be proved by biliary brushing, bile cytology, endobiliary biopsy under scope control with pediatric pliers, or by cytologic puncture under scan or echoendscopic control.
- Patient with Karnofsky score ≥ 50 %
- Patient with an efficient initial biliary drainage with prothesis.
- Cancer classified maximum T3N1M1, but only with intrahepatic metastasis occupying less than 25% of hepatic parenchyme (according to TNM cancer classification of extrahepatic biliary ducts' cancers).
- Patient capable of fill in the quality of life questionnaire.
Who cannot join
- No written informed consent.
- Type I and II cholangiocarcinoma according to Bismuth classification.
- Patients with ASA score 4.
- Patients with clinical and biological signs of biliary infection.
- Patients with a severe visceral disease other than cholangiocarcinoma.
- Patients without an efficient initial biliary drainage.
Show all 19Show fewer
- Patients with extrahepatic visceral metastasis, except perihilar ganglionic metastasis classified T4N1M+ according to TNM classification.
- Patients whose cholangiocarcinoma has already been resected.
- Patients under or already treated by radiotherapy or chemotherapy treatment for cholangiocarcinoma.
- Patients first treated with metallic prothesis.
- Patients with a contraindication to MRI.
- Patients with porphyria or hypersensibility to porphyrins.
- Patient treated by a non authorized treatment at the time of inclusion.
- Pregnant, parturient or breastfeeding women.
- Non menopaused woman without an efficient contraception.
- Patient under 18.
- Person over 18 under protection according to French Public Health Code.
- Person not affiliated to a social security regimen, or benefiting from such a regimen.
- Person in a exclusion period of another biomedical study.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
UH Amiens
Amiens, 80 000
UH Angers
Angers, 49933
H Beaujon
Clichy, 92 118
UH Henri Mondor
Créteil, 94 010
UH Kremlin Bicêtre
Le Kremlin-Bicêtre, 94 275
UH Claude Huriez
Lille, 59 037
Clinique Sainte Anne
Lyon, 69 003
UH La Timone
Marseille, 13 385
UH Marseille Nord
Marseille, 13 915
H Metz-Thionville
Metz, 57 038
UH Nantes
Nantes, 44 000
Clinique du Trocadéro
Paris, 75 116
UH Cochin
Paris, 75 679
UH La Milétrie
Poitiers, 86 021
UH Charles Nicolle
Rouen, 76 031
UH Hôpital Civil
Strasbourg, 67 091
UH Purpan
Toulouse, 31 059
UH Rangueil
Toulouse, 31 059
About this study
Official title: Efficiency Evaluation of Photodynamic Therapy With Photofrin® on Unresectable Type III or IV Cholangiocarcinomas - A Prospective, Multicentric and Randomized Study.
Unresectable type III or IV cholangiocarcinoma has a very bad prognosis; survival median ranges between 6 and 9 months.
Survival depends on biliary drainage quality, obtained by plastic or metallic prothesis setting up in one or several hepatic segments.
Read more
Radiotherapy and/or chemotherapy didn't prove yet their efficiency on survival. In France, gemcitabin is recommended by the French Digestive Oncology Federation in metastatic tumours, in monotherapy or associated with cisplatin or oxaliplatin (Gemox) for patients in good general condition.
Photodynamic therapy has shown in 3 prospective studies - one randomized - with small patient series, a significative efficiency on survival and quality of life of treated patients, in comparison with historical series, or patients' groups whose biliary drainage was in most cases unefficient.
A new randomized study, including patients whose biliary drainage is efficient and comparing their becoming when they are treated by PDT in addition to current practice, or only by current practice, seems to be justified.
The principal objective of this study is to evaluate the efficiency of PDT with Photofrin® on patients with unresectable type III or IV cholangiocarcinoma.
- Conditions
- Cholangiocarcinoma
- Being tested
- photodynamic therapy
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photodynamic therapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | PDT Receives: Procedure: photodynamic therapy |
| 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' survival compared between both groups : PDT and non-PDT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study startApr 2008
- Study completionNov 2009
Why it stopped: Big difficulties to enroll patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- 80 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Investigators
- Jean Boyer, MD, PhD, Principal investigator, UH Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540735
- Sponsor's protocol ID
- PHRC 2006-01
- Acronym
- CK/PDT
- Status last verified
- Oct 2007
- First submitted
- 5 Oct 2007
- Last updated
- 4 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency Evaluation of Photodynamic Therapy With Photofrin® on Unresectable Type III or IV Cholangiocarcinomas - A Prospective, Multicentric and Randomized Study.
- ClinicalTrials.gov ID
- NCT00540735
- Acronym / sponsor ID
- CK/PDT / PHRC 2006-01
- Conditions
- Cholangiocarcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Big difficulties to enroll patients
- Enrolment
- 80 participants
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Apr 2008
- Study completion
- Nov 2009
- First posted
- 8 Oct 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.
Unresectable type III or IV cholangiocarcinoma has a very bad prognosis; survival median ranges between 6 and 9 months.
Survival depends on biliary drainage quality, obtained by plastic or metallic prothesis setting up in one or several hepatic segments.
Radiotherapy and/or chemotherapy didn't prove yet their efficiency on survival. In France, gemcitabin is recommended by the French Digestive Oncology Federation in metastatic tumours, in monotherapy or associated with cisplatin or oxaliplatin (Gemox) for patients in good general condition.
Photodynamic therapy has shown in 3 prospective studies - one randomized - with small patient series, a significative efficiency on survival and quality of life of treated patients, in comparison with historical series, or patients' groups whose biliary drainage was in most cases unefficient.
A new randomized study, including patients whose biliary drainage is efficient and comparing their becoming when they are treated by PDT in addition to current practice, or only by current practice, seems to be justified.
The principal objective of this study is to evaluate the efficiency of PDT with Photofrin® on patients with unresectable type III or IV cholangiocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: photodynamic therapyPDT |
| 2 | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Obtention of a written informed consent.
- Patient over 18.
- Patient with a type III or IV (according to Bismuth classification) histologically proved cholangiocarcinoma ; histologic diagnosis must be proved by biliary brushing, bile cytology, endobiliary biopsy under scope control with pediatric pliers, or by cytologic puncture under scan or echoendscopic control.
- Patient with Karnofsky score ≥ 50 %
- Patient with an efficient initial biliary drainage with prothesis.
Key exclusion criteria (19 listed)
- No written informed consent.
- Type I and II cholangiocarcinoma according to Bismuth classification.
- Patients with ASA score 4.
- Patients with clinical and biological signs of biliary infection.
- Patients with a severe visceral disease other than cholangiocarcinoma.
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 |
|---|---|---|
| photodynamic therapy | Procedure or surgery | 1 |
Primary outcome
Patients' survival compared between both groups : PDT and non-PDT.
Results and safety
The study was stopped early (reason given: Big difficulties to enroll patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2010.
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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.
Jean Boyer, MD, PhD principal investigator
UH Angers
18 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 photodynamic therapy in people with Cholangiocarcinoma, run by University Hospital, Angers at 18 sites in France.
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 19 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: stopped early, as of the sponsor's last update on 4 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France. 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 was stopped early (reason given: Big difficulties to enroll patients). Results are not available in the source record.
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?
Patients' survival compared between both groups : PDT and non-PDT.. 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 4 Feb 2010.