Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that was terminated before completion, run by Concordia Laboratories. The registered enrollment target is 28 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02082522
The ClinicalTrials.gov registry entry for NCT02082522 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Concordia Laboratories, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Photodynamic therapy-Photofrin is the first listed.
NCT02082522 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.