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

Primary Purpose

Hilar Cholangiocarcinoma

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Photodynamic therapy-Photofrin
Stenting procedure
Chemotherapy regimen
Sponsored by
Concordia Laboratories Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hilar Cholangiocarcinoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

  • Western Regional Medical Center, Inc.
  • Mayo Clinic Cancer Center
  • University of Southern California Keck School of Medicine
  • UC Davis Medical Center
  • University of Colorado Denver
  • Oschner Medical Center
  • Henry Ford Health System
  • SUNY Downstate Medical Center
  • Roswell Park Cancer Institute
  • Weill Cornell Medical College
  • Columbia University Medical Center
  • Duke University Medical Center
  • Southwestern Regional Medical Center, Inc.
  • Thomas Jefferson University
  • Allegheny Center for Digestive Health - AHN ASRI
  • Methodist Dallas Medical Center
  • Virginia Mason Medical Center
  • Providence Sacred Heart Medical Center and Children's Hospital
  • St. Michael's Hospital
  • CHUM Hôpital St-Luc
  • Klinikum Ludwigsburg
  • Klinikum Mannheim GmbH
  • Johann-Wolfgang-Goethe Universität Frankfurt
  • Medizinische Hochschule Hannover
  • Universitätsklinikum Essen (AöR)
  • Konkuk University Medical Center
  • Soonchunhyang University Bucheon Hospital
  • Seoul National University Bundang Hospital
  • Severance Hospital, Yonsei University Health System
  • Seoul National University Hospital
  • UniversitätsSpital Zürich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Photodynamic therapy-Photofrin plus SMC

Standard Medical Care (SMC)

Arm Description

Photodynamic 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.

Standard 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time-to-bilirubin Response
From the date of randomization until the date of first documented bilirubin response
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)
Time-to-tumor Progression
From the date of first documented response until the date that tumor progression was assessed
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 6, 2014
Last Updated
August 14, 2019
Sponsor
Concordia Laboratories Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02082522
Brief Title
Efficacy and Safety Study of PDT Using Photofrin in Unresectable Advanced Perihilar Cholangiocarcinoma (OPUS)
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
Accrual rate remaining too low
Study Start Date
November 12, 2014 (Actual)
Primary Completion Date
January 12, 2017 (Actual)
Study Completion Date
January 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Concordia Laboratories Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hilar Cholangiocarcinoma
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Photodynamic therapy-Photofrin plus SMC
Arm Type
Experimental
Arm Description
Photodynamic 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.
Arm Title
Standard Medical Care (SMC)
Arm Type
Active Comparator
Arm Description
Standard 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.
Intervention Type
Drug
Intervention Name(s)
Photodynamic therapy-Photofrin
Other Intervention Name(s)
PDT-Photofrin
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Stenting procedure
Other Intervention Name(s)
Stents placement
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy regimen
Other Intervention Name(s)
Gemcitabine/Cisplatin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Survival Time
Description
Time from the date of randomization until the date of death or the last date the subject was known to be alive
Time Frame
Up to 26 months
Secondary Outcome Measure Information:
Title
Time-to-bilirubin Response
Description
From the date of randomization until the date of first documented bilirubin response
Time Frame
Up to 30 days
Title
Best Overall Tumor Response as Measured by the RECIST 1.1 Criteria (Response Evaluation Criteria in Solid Tumors)
Description
From the start of the treatment until disease progression or recurrence the RECIST 1.1 criteria are applied (Response Evaluation Criteria in Solid Tumors)
Time Frame
Up to 26 months
Title
Time-to-tumor Progression
Description
From the date of first documented response until the date that tumor progression was assessed
Time Frame
Up to 26 months
Title
Change From Baseline on Karnofsky Performance Scale (KPS)
Description
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.
Time Frame
Baseline, 7 days
Title
Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)
Description
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.
Time Frame
Baseline, up to 4 weeks
Title
Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)
Description
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.
Time Frame
Baseline, 13 weeks
Title
Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)
Description
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.
Time Frame
Baseline, 16 weeks
Title
Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)
Description
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.
Time Frame
Baseline, 29 weeks
Title
Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)
Description
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.
Time Frame
Baseline, 41 weeks
Title
Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)
Description
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.
Time Frame
Baseline, 54 weeks
Title
Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)
Description
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.
Time Frame
Baseline, 66 weeks
Title
Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)
Description
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.
Time Frame
Baseline, 78 weeks
Title
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)
Description
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.
Time Frame
Baseline, 7 days
Title
Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30
Description
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.
Time Frame
Baseline, up to 4 weeks
Title
Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30
Description
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.
Time Frame
Baseline, 13 weeks
Title
Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30
Description
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.
Time Frame
Baseline, 16 weeks
Title
Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30
Description
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.
Time Frame
Baseline, 29 weeks
Title
Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30
Description
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.
Time Frame
Baseline, 41 weeks
Title
Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30
Description
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.
Time Frame
Baseline, 54 weeks
Title
Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30
Description
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.
Time Frame
Baseline, 66 weeks
Title
Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30
Description
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.
Time Frame
Baseline, 78 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Kahaleh, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Regional Medical Center, Inc.
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85338
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5499
Country
United States
Facility Name
University of Southern California Keck School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-1026
Country
United States
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Oschner Medical Center
City
Kenner
State/Province
Louisiana
ZIP/Postal Code
70065
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Southwestern Regional Medical Center, Inc.
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Allegheny Center for Digestive Health - AHN ASRI
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Methodist Dallas Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Providence Sacred Heart Medical Center and Children's Hospital
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
CHUM Hôpital St-Luc
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3J4
Country
Canada
Facility Name
Klinikum Ludwigsburg
City
Ludwigsburg
State/Province
Baden Wuerttemberg
ZIP/Postal Code
71640
Country
Germany
Facility Name
Klinikum Mannheim GmbH
City
Mannheim
State/Province
Baden Wuerttemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
Johann-Wolfgang-Goethe Universität Frankfurt
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Essen (AöR)
City
Essen
State/Province
Nordrhein Westfalen
ZIP/Postal Code
D-45147
Country
Germany
Facility Name
Konkuk University Medical Center
City
Seoul
State/Province
Gwangjin-gu
ZIP/Postal Code
143-729
Country
Korea, Republic of
Facility Name
Soonchunhyang University Bucheon Hospital
City
Bucheon City
State/Province
Gyeonggi-do
ZIP/Postal Code
420-767
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
State/Province
Seodaemun-gu
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
UniversitätsSpital Zürich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The study was prematurely discontinued meaning only descriptive analyses are possible. It is not feasible to share this sort of data.

Learn more about this trial

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

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