Efficacy and Safety Study of PDT Using Photofrin in Unresectable Advanced Perihilar Cholangiocarc… (NCT02082522) | Clinical Trial Compass
TerminatedPhase 3
Efficacy and Safety Study of PDT Using Photofrin in Unresectable Advanced Perihilar Cholangiocarcinoma (OPUS)
Stopped: Accrual rate remaining too low
United States, Canada, Germany28 participantsStarted 2014-11-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Males or females aged 18 or older
* Diagnosed with radiologically and biopsy or cytology confirmed inoperable perihilar cholangiocarcinoma Bismuth Tumor Stage III/IV
* Non-menopausal or non-sterile female subjects of childbearing potential must have a negative serum beta-HCG and use a medically acceptable form of birth control
* Able to sign an informed consent
Exclusion Criteria:
* Diagnostic of cholangiocarcinoma made more than 45 days prior to randomization
* Cholangiocarcinoma with extra-hepatic metastasis or concurrent non-solid malignancy
* Presence or history of other neoplasms (treated during the last five years prior to study entry) other than carcinoma in situ of the cervix or basal carcinoma of the skin
* Previously received photodynamic therapy for cholangiocarcinoma
* Previously undergone surgical resection of the cholangiocarcinoma
* Previously undergone chemotherapy, brachytherapy, or radiotherapy prior to entering the study
* Previously undergone metal stent insertion
* Porphyria or hypersensitivity to porphyrins (constituents of porfimer sodium), gemcitabine, cisplatin or other platinum-containing compounds
* Presence of infection other than the infection of the bile duct (cholangitis)
* Acute or chronic medical or psychological illnesses that prevent endoscopy procedures
* Abnormal blood test results
* Severe impairment of your kidney or liver function
* Decompensated cirrhosis
* Pregnant or intend to become pregnant, breastfeeding o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before it finished — can you help me understand what that means for the reliability of the survival data collected, and whether the results still tell us anything useful about photodynamic therapy with Photofrin for my type of bile duct cancer?
2Since this was a Phase 3 trial focused on overall survival in unresectable perihilar cholangiocarcinoma, what do the partial or final results suggest about how PDT with Photofrin compares to the standard treatments available to me right now?
3Photodynamic therapy requires light activation after the drug is given, which can involve specific procedural steps and light-sensitivity precautions — given that this trial was studying it in a complex cancer like hilar cholangiocarcinoma, how practical and safe would PDT be as part of my care at this stage?
4Because the trial was terminated, are there other active or completed studies on PDT or other local treatments for unresectable perihilar cholangiocarcinoma that you think I should know about before we decide on a treatment path?
5Given that my tumor is considered unresectable, how does photodynamic therapy with Photofrin fit into the broader picture of my options — including biliary stenting, chemotherapy, or other palliative approaches — and what would guide your recommendation for me specifically?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.