CholangiocarcinomaPhase 3PDTNCT00907413
Photodynamic Therapy (PDT) Trial for Palliation of Cholangiocarcinoma
A Phase 3 study testing ERCP and Photodynamic Therapy and ERCP only in people with Cholangiocarcinoma, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This research study is a phase III double arm, multicenter, randomized controlled clinical trial comparing endoscopic retrograde cholangiopancreatography (ERCP) and stenting plus photodynamic therapy (PDT) versus ERCP with stenting alone in adult patients with unresectable cholangiocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- ERCP and Photodynamic Therapy and ERCP only
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Jun 2011
- 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
- Patient is age 18 years or older
- Patient is diagnosed with non-resectable cholangiocarcinoma, as determined by CT within 30 days of enrollment and CT shows Bismuth Tumor Stage as: IIIa, IIIb, IV (Bismuth tumor stage I and II are not eligible to participate)
- Patients must have adequate organ and marrow function as defined below:
- Patient's INR ≤ 2 within 30 days of treatment
- Patient's platelets > 50,000/cmm within 30 days of treatment
- Patient's Absolute Neutrophil Count (ANC) > 1,500/cmm within 30 days of treatment
- Patient's creatinine ≤ 3 mg/dL within 30 days of treatment
- Patient has the ability to understand and the willingness to comply with the study procedures and provide written informed consent to participate in the study
Who cannot join
- Patient was diagnosed with cholangiocarcinoma more than 3 months ago
- Patient has any metastatic disease
- Patient has acute porphyria
- Subjects exhibiting neurologic or cutaneous symptoms will undergo urinary delta-aminolevulinic acid and porphobilinogen dosage tests to determine severity.
- Patient is pregnant (Women of child bearing age must have a negative pregnancy test prior to registration and must agree to use adequate contraception during study therapy)
- Patient has a concurrent non solid malignancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlotteville, Virginia, 22908
About this study
Official title: Photodynamic Therapy for Palliation of Unresectable Cholangiocarcinoma A Multicenter, Open Label, Randomized, Controlled Phase III Trial
This research study is a phase III double arm, multicenter, randomized controlled clinical trial comparing endoscopic retrograde cholangiopancreatography (ERCP) and stenting plus photodynamic therapy (PDT) versus ERCP with stenting alone in adult patients with unresectable cholangiocarcinoma.
The study objectives are to investigate the efficacy of photodynamic therapy (PDT) in increasing the survival time of patients with unresectable cholangiocarcinoma and to assess the effect of PDT on both cholestasis and health-related quality of life (HRQoL).
Read the detailed description
The study objectives are to investigate the efficacy of photodynamic therapy (PDT) in increasing the survival time of patients with unresectable cholangiocarcinoma and to assess the effect of PDT on both cholestasis and health-related quality of life (HRQoL).
- Conditions
- Cholangiocarcinoma
- Being tested
- ERCP and Photodynamic Therapy, ERCP only
- Keywords
- cancer, bile duct
- Medical subject headings
- Cholangiocarcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCP and Photodynamic TherapyProcedure or surgery
Photodynamic Therapy is a new therapeutic approach that specifically targets neoplastic cells. This therapy has been used in other tumors as a local treatment and involves the intravenous administration of a photosensitizing agent followed by activation of the agent by illumination with non-thermal light of a specific wavelength, resulting in cell death from direct cytotoxicity and ischemic necrosis. Cytotoxicity is directly proportional to tissue oxygenation.
ERCP onlyProcedure or surgery
Endoscopic retrograde cholangiopancreatography and stenting.
| Study group | Role | What they receive |
|---|---|---|
| ERCP and PDT | Experimental | Endoscopic Retrograde Cholangio Pancreatography (ERCP) and stenting combined with Photodynamic Dynamic Therapy ERCP and PDT Receives: Procedure: ERCP and Photodynamic Therapy; Procedure: ERCP only |
| ERCP alone | Active comparator | Endoscopic Retrograde Cholangio Pancreatography (ERCP) with stenting alone Receives: Procedure: ERCP only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival time in each group will be compared as well as effect of each treatment arm on cholestasis and HRQoL
Measured: 2.4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2009 (estimated)
- Study startMay 2010
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: PI relocated and reopened trial in new university
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 Weill Medical College of Cornell UniversityThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michel Kahaleh, Weill Medical College of Cornell University
- Investigators
- Michel Kahaleh, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907413
- Sponsor's protocol ID
- 13898
- Acronym
- PDT
- Status last verified
- Jun 2015
- First submitted
- 21 May 2009
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cerecedo-Rodriguez J, Phillips M, Figueroa-Barojas P, Kumer SC, Gaidhane M, Schmitt T, Kahaleh M. Self expandable metal stents for anastomotic stricture following liver transplant. Dig Dis Sci. 2013 Sep;58(9):2661-6. doi: 10.1007/s10620-013-2703-0. Epub 2013 May 24.
PubMed 23703448
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photodynamic Therapy for Palliation of Unresectable Cholangiocarcinoma A Multicenter, Open Label, Randomized, Controlled Phase III Trial
- ClinicalTrials.gov ID
- NCT00907413
- Acronym / sponsor ID
- PDT / 13898
- Conditions
- Cholangiocarcinoma
- Keywords
- cancer, bile duct
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI relocated and reopened trial in new university
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 22 May 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.
This research study is a phase III double arm, multicenter, randomized controlled clinical trial comparing endoscopic retrograde cholangiopancreatography (ERCP) and stenting plus photodynamic therapy (PDT) versus ERCP with stenting alone in adult patients with unresectable cholangiocarcinoma.
The study objectives are to investigate the efficacy of photodynamic therapy (PDT) in increasing the survival time of patients with unresectable cholangiocarcinoma and to assess the effect of PDT on both cholestasis and health-related quality of life (HRQoL).
Detailed description
The study objectives are to investigate the efficacy of photodynamic therapy (PDT) in increasing the survival time of patients with unresectable cholangiocarcinoma and to assess the effect of PDT on both cholestasis and health-related quality of life (HRQoL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERCP and PDT | Experimental | Procedure: ERCP and Photodynamic Therapy, Procedure: ERCP onlyEndoscopic Retrograde Cholangio Pancreatography (ERCP) and stenting combined with Photodynamic Dynamic Therapy ERCP and PDT |
| ERCP alone | Active comparator | Procedure: ERCP onlyEndoscopic Retrograde Cholangio Pancreatography (ERCP) with stenting alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient is age 18 years or older
- Patient is diagnosed with non-resectable cholangiocarcinoma, as determined by CT within 30 days of enrollment and CT shows Bismuth Tumor Stage as: IIIa, IIIb, IV (Bismuth tumor stage I and II are not eligible to participate)
- Patients must have adequate organ and marrow function as defined below:
- Patient has the ability to understand and the willingness to comply with the study procedures and provide written informed consent to participate in the study
Key exclusion criteria (6 listed)
- Patient was diagnosed with cholangiocarcinoma more than 3 months ago
- Patient has any metastatic disease
- Patient has acute porphyria
- Subjects exhibiting neurologic or cutaneous symptoms will undergo urinary delta-aminolevulinic acid and porphobilinogen dosage tests to determine severity.
- Patient is pregnant (Women of child bearing age must have a negative pregnancy test prior to registration and must agree to use adequate contraception during study therapy)
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 |
|---|---|---|
| ERCP and Photodynamic TherapyPhotodynamic Therapy is a new therapeutic approach that specifically targets neoplastic cells. This therapy has been used in other tumors as a local treatment and involves the intravenous administration of a photosensitizing agent followed by activation of the agent by illumination with non-thermal light of a specific wavelength, resulting in cell death from direct cytotoxicity and ischemic necrosis. Cytotoxicity is directly proportional to tissue oxygenation. | Procedure or surgery | ERCP and PDT |
| ERCP onlyEndoscopic retrograde cholangiopancreatography and stenting. | Procedure or surgery | ERCP alone, ERCP and PDT |
Primary outcome
Survival time in each group will be compared as well as effect of each treatment arm on cholestasis and HRQoL
Time frame: 2.4 years
Results and safety
The study was stopped early (reason given: PI relocated and reopened trial in new university). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
- Derived from this study: PubMed 23703448Cerecedo-Rodriguez J, Phillips M, Figueroa-Barojas P, Kumer SC, Gaidhane M, Schmitt T, Kahaleh M. Self expandable metal stents for anastomotic stricture following liver transplant. Dig Dis Sci. 2013 Sep;58(9):2661-6. doi: 10.1007/s10620-013-2703-0. Epub 2013 May 24.
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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.
Michel Kahaleh, MD principal investigator
University of Virginia
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 ERCP and Photodynamic Therapy and ERCP only in people with Cholangiocarcinoma, run by Weill Medical College of Cornell University at 1 site in United States.
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 8 inclusion and 6 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 3 Jun 2015. 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 United States. 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: PI relocated and reopened trial in new university). 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?
Survival time in each group will be compared as well as effect of each treatment arm on cholestasis and HRQoL (time frame: 2.4 years). 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 NCT00907413, 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 3 Jun 2015.