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Hilar CholangiocarcinomaPhase 3NCT02082522

Efficacy and Safety Study of PDT Using Photofrin in Unresectable Advanced Perihilar Cholangiocarcinoma (OPUS)

A Phase 3 study testing Photodynamic therapy-Photofrin, Stenting procedure and Chemotherapy regimen in people with Hilar Cholangiocarcinoma, run by Concordia Laboratories Inc. at 31 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hilar Cholangiocarcinoma
What is being tested?
Photodynamic therapy-Photofrin, Stenting procedure and Chemotherapy regimen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
31 sitesin 5 countries
Study dates
12 Nov 2014to 12 Jan 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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 or intend to breast-feed during this study
  • Participated in another drug study within 90 days before this one
  • Unable or unwilling to complete the follow-up evaluations required for the study

Trial locations and contacts

31 sites in 5 countries.

31 sites in 5 countries

United States18 sites

  • University of Colorado Denver

    Aurora, Colorado, 80045

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Methodist Dallas Medical Center

    Dallas, Texas, 75208

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Western Regional Medical Center, Inc.

    Goodyear, Arizona, 85338

  • Oschner Medical Center

    Kenner, Louisiana, 70065

  • University of Southern California Keck School of Medicine

    Los Angeles, California, 90033-1026

  • Weill Cornell Medical College

    New York, New York, 10021

  • Columbia University Medical Center

    New York, New York, 10032

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Allegheny Center for Digestive Health - AHN ASRI

    Pittsburgh, Pennsylvania, 15212

  • UC Davis Medical Center

    Sacramento, California, 95817

  • Mayo Clinic Cancer Center

    Scottsdale, Arizona, 85259-5499

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Providence Sacred Heart Medical Center and Children's Hospital

    Spokane, Washington, 99204

  • Southwestern Regional Medical Center, Inc.

    Tulsa, Oklahoma, 74133

Other trials in United States

Germany5 sites

  • Universitätsklinikum Essen (AöR)

    Essen, North Rhine-Westphalia, D-45147

  • Johann-Wolfgang-Goethe Universität Frankfurt

    Frankfurt am Main, Hesse, 60590

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625

  • Klinikum Ludwigsburg

    Ludwigsburg, Baden-Wurttemberg, 71640

  • Klinikum Mannheim GmbH

    Mannheim, Baden-Wurttemberg, 68167

Other trials in Germany

South Korea5 sites

  • Soonchunhyang University Bucheon Hospital

    Bucheon-si, Gyeonggi-do, 420-767

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 463-707

  • Konkuk University Medical Center

    Seoul, Gwangjin-gu, 143-729

  • Severance Hospital, Yonsei University Health System

    Seoul, Seodaemun-gu, 120-752

  • Seoul National University Hospital

    Seoul, 110-744

Other trials in South Korea

Canada2 sites

  • CHUM Hôpital St-Luc

    Montreal, Quebec, H2X 3J4

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

Other trials in Canada

Switzerland1 site

  • UniversitätsSpital Zürich

    Zurich, 8091

Other trials in Switzerland

About this study

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

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.

Read the detailed description

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.

Cholangiocarcinoma (CCA) is defined as primary malignant tumors of the bile ducts. The exact etiology remains unknown. These cancerous tumors block the bile flow and can be intrahepatic (IH) or extrahepatic (EH). The distinction between IH- and EH-CCA has become increasingly important, as the epidemiological features (i.e., incidence and risk factors), the biologic and pathologic characteristics and the clinical course are largely different. Unfortunately, most subjects are found to have metastases or unresectable disease at the time of diagnosis. Median survival for subjects with unresectable perihilar-CCA varies between five and eight months. The one-year survival is 50%, with 20% surviving at two years and 10% at three years. Unresected CCA is a rapidly fatal process with cholangitis being a significant cause of morbidity and mortality in these subjects.

This study was designed to confirm the efficacy of PHOPDT + standard medical care (SMC) defined as stents plus gemcitabine/cisplatin chemotherapy regimen on the overall survival of subjects with unresectable cholestasis perihilar Bismuth type III or IV - tumor TNM stage III or IVa CCA.

Being tested
Photodynamic therapy-Photofrin, Stenting procedure, Chemotherapy regimen
Keywords
Cholangiocarcinoma, Unresectable perihilar cholangiocarcinoma, Klatskin tumor, Photodynamic therapy, Porfimer sodium, Photofrin, Gemcitabine, Cisplatin, Stents, CCA, PDT, Bile duct cancer, Bile duct tumor, Bile duct adenocarcinoma, Chemotherapy
Medical subject headings
Klatskin Tumor, Cholangiocarcinoma, Bile Duct Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Photodynamic therapy-PhotofrinDrug

    Also called PDT-Photofrin

    Photodynamic therapy (PDT) involves the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device during an endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC). Two days after the injection, a laser light (180 J/cm(2)) will be applied to the tumor. A second light application will be given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients will undergo stenting as part of standard medical care procedure. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) may be given at 3-month intervals.

  • Stenting procedureProcedure or surgery

    Also called Stents placement

    As per standard medical procedures, stenting procedure consists in the placement of stents above the main tumors of the right and left hepatic bile ducts via endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) when the ERCP approach has been unsuccessful.

  • Chemotherapy regimenDrug

    Also called Gemcitabine/Cisplatin

    The regimen will comprise gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen may be administered if there is no disease progression or intolerable toxicity.

Study groups in NCT02082522
Study groupRoleWhat they receive
Photodynamic therapy-Photofrin plus SMCExperimentalPhotodynamic therapy (PDT) involves the i.v. injection of Photofrin followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) will be applied to the tumor. A second light application will be given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients will undergo stenting as part of standard medical care procedure. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) may be given at 3-month intervals. Standard Medical Care (SMC) is defined as stenting procedure plus chemotherapy regimen.
Receives: Drug: Photodynamic therapy-Photofrin; Procedure: Stenting procedure; Drug: Chemotherapy regimen
Standard Medical Care (SMC)Active comparatorStandard Medical Care (SMC) is defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen will comprise gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen may be administered if there is no disease progression or intolerable toxicity.
Receives: Procedure: Stenting procedure; Drug: Chemotherapy regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival Time

    Time from the date of randomization until the date of death or the last date the subject was known to be alive

    Measured: Up to 26 months

Secondary outcomes (21)

  1. Time-to-bilirubin Response

    From the date of randomization until the date of first documented bilirubin response

    Measured: Up to 30 days

  2. Best Overall Tumor Response as Measured by the RECIST 1.1 Criteria (Response Evaluation Criteria in Solid Tumors)

    From the start of the treatment until disease progression or recurrence the RECIST 1.1 criteria are applied (Response Evaluation Criteria in Solid Tumors)

    Measured: Up to 26 months

  3. Time-to-tumor Progression

    From the date of first documented response until the date that tumor progression was assessed

    Measured: Up to 26 months

  4. Change From Baseline on Karnofsky Performance Scale (KPS)

    The Karnofsky Performance Scale scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is normal activity with effort and some signs or symptoms of disease.

    Measured: Baseline, 7 days

  5. Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)

    The Karnofsky Performance Scale (KPS) scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. A score of 100% means there are no complaints and no evidence of disease. A score of 80% means there is normal activity with effort and some signs or symptoms of disease. A score of 0% means death.

    Measured: Baseline, up to 4 weeks

  6. Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)

    The Karnofsky Performance Scale (KPS) scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. A score of 100% means there are no complaints and no evidence of disease. A score of 80% means there is normal activity with effort and some signs or symptoms of disease. A score of 0% means death.

    Measured: Baseline, 13 weeks

  7. Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)

    The Karnofsky Performance Scale (KPS) scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. A score of 100% means there are no complaints and no evidence of disease. A score of 80% means there is normal activity with effort and some signs or symptoms of disease. A score of 0% means death.

    Measured: Baseline, 16 weeks

  8. Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)

    The Karnofsky Performance Scale scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is normal activity with effort and some signs or symptoms of disease.

    Measured: Baseline, 29 weeks

  9. Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)

    The Karnofsky Performance Scale scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is normal activity with effort and some signs or symptoms of disease.

    Measured: Baseline, 41 weeks

  10. Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)

    The Karnofsky Performance Scale scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is normal activity with effort and some signs or symptoms of disease.

    Measured: Baseline, 54 weeks

  11. Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)

    The Karnofsky Performance Scale scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is normal activity with effort and some signs or symptoms of disease.

    Measured: Baseline, 66 weeks

  12. Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)

    The Karnofsky Performance Scale scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is normal activity with effort and some signs or symptoms of disease.

    Measured: Baseline, 78 weeks

  13. Change From Baseline in Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30)

    Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.

    Measured: Baseline, 7 days

  14. Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30

    Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.

    Measured: Baseline, up to 4 weeks

  15. Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30

    Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.

    Measured: Baseline, 13 weeks

  16. Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30

    Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.

    Measured: Baseline, 16 weeks

  17. Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30

    Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.

    Measured: Baseline, 29 weeks

  18. Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30

    Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.

    Measured: Baseline, 41 weeks

  19. Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30

    Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.

    Measured: Baseline, 54 weeks

  20. Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30

    Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.

    Measured: Baseline, 66 weeks

  21. Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30

    Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.

    Measured: Baseline, 78 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2014 (estimated)
  2. Study start12 Nov 2014
  3. Primary completion12 Jan 2017
  4. Study completion12 Jan 2017

Why it stopped: Accrual rate remaining too low

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02082522
Sponsor's protocol ID
PIN-PHO1201
Status last verified
Aug 2019
First submitted
6 Mar 2014
Last updated
28 Aug 2019
Data monitoring committee
Yes
Individual data sharing
No: The study was prematurely discontinued meaning only descriptive analyses are possible. It is not feasible to share this sort of data.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Photodynamic therapy-Photofrin, Stenting procedure and Chemotherapy regimen in people with Hilar Cholangiocarcinoma, run by Concordia Laboratories Inc. at 31 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, Germany, South Korea, Canada, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival Time (time frame: Up to 26 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02082522.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.

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