Efficacy and Safety Study of PDT Using Photofrin in Unresectable Advanced Perihilar Cholangiocarcinoma (OPUS)
Public ClinicalTrials.gov record NCT02082522. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Multicenter, Open-label, Randomized, Controlled Phase III Clinical Study of the Efficacy and Safety of Photodynamic Therapy Using Porfimer Sodium for Injection as Treatment for Unresectable Advanced Perihilar Cholangiocarcinoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Photodynamic therapy (PDT) is a combination of a drug, porfimer sodium (Photofrin), which is activated by a light from a laser that emits no heat. This technique works to allow the medical doctor to specifically target and destroy abnormal or cancer cells while limiting damage to surrounding healthy tissue. The activation of the drug is done by lighting the abnormal areas using a fiber optic device (very fine fiber like a fishing line that permits light transmission) inserted into a flexible tube with a light called cholangioscope for the bile duct. The light will activate the porfimer sodium concentrated in the abnormal tissue, leading to its destruction. This research study will evaluate the efficacy and safety of PDT with porfimer sodium administered with Standard Medical Care (SMC) compared to SMC alone on the overall survival time of patients with non-operable advanced cholangiocarcinoma, a rare cancer of the bile ducts. It will involve 200 patients across North America and Europe. Other countries may participate if needed. Participation will last at least 18 months.
Study identification
- NCT ID
- NCT02082522
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 28 participants
Conditions and interventions
Conditions
Interventions
- Photodynamic therapy-Photofrin Drug
- Stenting procedure Procedure
- Chemotherapy regimen Drug
Drug · Procedure
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 12, 2014 (Actual)
- Primary completion
- Jan 12, 2017 (Actual)
- Completion
- Jan 12, 2017 (Actual)
- Last update posted
- Aug 28, 2019
2014 – 2017
United States locations
- U.S. sites
- 18
- U.S. states
- 11
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Western Regional Medical Center, Inc. | Goodyear | Arizona | 85338 | — |
| Mayo Clinic Cancer Center | Scottsdale | Arizona | 85259-5499 | — |
| University of Southern California Keck School of Medicine | Los Angeles | California | 90033-1026 | — |
| UC Davis Medical Center | Sacramento | California | 95817 | — |
| University of Colorado Denver | Aurora | Colorado | 80045 | — |
| Oschner Medical Center | Kenner | Louisiana | 70065 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| SUNY Downstate Medical Center | Brooklyn | New York | 11203 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| Weill Cornell Medical College | New York | New York | 10021 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Southwestern Regional Medical Center, Inc. | Tulsa | Oklahoma | 74133 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Allegheny Center for Digestive Health - AHN ASRI | Pittsburgh | Pennsylvania | 15212 | — |
| Methodist Dallas Medical Center | Dallas | Texas | 75208 | — |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | — |
| Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington | 99204 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 13 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02082522, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 28, 2019 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02082522 live on ClinicalTrials.gov.