Photodynamic Therapy (PDT) Trial for Palliation of Cholangiocarcinoma
This study has been terminated.
(PI relocated and reopened trial in new university)
Sponsor:
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Michel Kahaleh, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00907413
First received: May 21, 2009
Last updated: December 18, 2012
Last verified: December 2012
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Cholangiocarcinoma |
Procedure: ERCP and Photodynamic Therapy Procedure: ERCP only |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Photodynamic Therapy for Palliation of Unresectable Cholangiocarcinoma A Multicenter, Open Label, Randomized, Controlled Phase III Trial |
Resource links provided by NLM:
Further study details as provided by Weill Medical College of Cornell University:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 50 |
| Study Start Date: | May 2010 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ERCP and PDT
Endoscopic Retrograde Cholangio Pancreatography (ERCP) and stenting combined with Photodynamic Dynamic Therapy ERCP and PDT
|
Procedure: ERCP and Photodynamic Therapy
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.
Procedure: ERCP only
Endoscopic retrograde cholangiopancreatography and stenting.
|
|
Active Comparator: ERCP alone
Endoscopic Retrograde Cholangio Pancreatography (ERCP) with stenting alone
|
Procedure: ERCP only
Endoscopic retrograde cholangiopancreatography and stenting.
|
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00907413
Locations
| United States, Virginia | |
| University of Virginia | |
| Charlotteville, Virginia, United States, 22908 | |
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
| Principal Investigator: | Michel Kahaleh, MD | University of Virginia |
More Information
No publications provided
| Responsible Party: | Michel Kahaleh, Chief of Endoscopy, Weill Medical College of Cornell University |
| ClinicalTrials.gov Identifier: | NCT00907413 History of Changes |
| Other Study ID Numbers: | 13898 |
| Study First Received: | May 21, 2009 |
| Last Updated: | December 18, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Weill Medical College of Cornell University:
|
cancer bile duct |
Additional relevant MeSH terms:
|
Cholangiocarcinoma Adenocarcinoma Carcinoma |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on May 19, 2013