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NCT02082522 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of PDT Using Photofrin in Unresectable Advanced Perihilar Cholangiocarcinoma (OPUS)
A Phase 3 study, sponsored by Concordia Laboratories.
- Terminated
- Registry status
- Phase 3
- Development phase
- 28
- Enrollment target
NCT02082522: Clinical Trial Phase 3 study, sponsored by Concordia Laboratories.
NCT02082522 is a Phase 3 study that was terminated before completion, run by Concordia Laboratories. The registered enrollment target is 28 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02082522, a Phase 3 study, was terminated before completion, sponsored by Concordia Laboratories.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 28 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Time from the date of randomization until the date of death or the last date the subject was known to be alive
Interventions
- DRUG Photodynamic therapy-Photofrin
- PROCEDURE Stenting procedure
- DRUG Chemotherapy regimen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2014-11-12 |
| Est. Completion | 2017-01-12 |
| Phase | Phase 3 |
Why NCT02082522 stopped before completion
NCT02082522 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which Photodynamic therapy-Photofrin is the first listed.
NCT02082522 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02082522 about?
NCT02082522 is a clinical study titled "Efficacy and Safety Study of PDT Using Photofrin in Unresectable Advanced Perihilar Cholangiocarcinoma (OPUS)". 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...
What is the current status of trial NCT02082522?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 28 participants. The study started on 2014-11-12. Estimated completion is 2017-01-12.
What interventions are being tested in trial NCT02082522?
The interventions under investigation include: Photodynamic therapy-Photofrin (DRUG), Stenting procedure (PROCEDURE), Chemotherapy regimen (DRUG).
Who is sponsoring clinical trial NCT02082522?
This trial is sponsored by Concordia Laboratories, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02082522's enrollment target sits among peer trials
28 1935th of 2000 higher than 65 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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