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Accrual rate remaining too low
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Photodynamic therapy-Photofrin plus SMC | Experimental | 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) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photodynamic therapy-Photofrin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 26 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-bilirubin Response | From the date of randomization until the date of first documented bilirubin response | Up to 30 days |
| Best Overall Tumor Response as Measured by the RECIST 1.1 Criteria (Response Evaluation Criteria in Solid Tumors) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michel Kahaleh, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Regional Medical Center, Inc. | Goodyear | Arizona | 85338 | United States | ||
| Mayo Clinic Cancer Center |
The study was prematurely discontinued meaning only descriptive analyses are possible. It is not feasible to share this sort of data.
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An independent expert panel acted as central assessors for subjects across all sites. Central assessors prospectively interpreted all abdominal CT and cholangiogram images taken at screening to establish the final diagnosis and to confirm the randomization. Central assessors had the authority to overrule the investigator's diagnosis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Photodynamic Therapy-Photofrin Plus SMC | Photodynamic therapy (PDT) involved the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) was applied to the tumor. A second light application was given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients underwent stenting. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) could be given at 3-month intervals. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. The chemotherapy regimen comprised 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 could be administered if there was no disease progression or intolerable toxicity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Stenting procedure | Procedure | 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 regimen | Drug | 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. |
|
|
From the start of the treatment until disease progression or recurrence the RECIST 1.1 criteria are applied (Response Evaluation Criteria in Solid Tumors)
| Up to 26 months |
| Time-to-tumor Progression | From the date of first documented response until the date that tumor progression was assessed | Up to 26 months |
| 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. | Baseline, 7 days |
| 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. | Baseline, up to 4 weeks |
| 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. | Baseline, 13 weeks |
| 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. | Baseline, 16 weeks |
| 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. | Baseline, 29 weeks |
| 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. | Baseline, 41 weeks |
| 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. | Baseline, 54 weeks |
| 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. | Baseline, 66 weeks |
| 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. | Baseline, 78 weeks |
| 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. | Baseline, 7 days |
| 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. | Baseline, up to 4 weeks |
| 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. | Baseline, 13 weeks |
| 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. | Baseline, 16 weeks |
| 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. | Baseline, 29 weeks |
| 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. | Baseline, 41 weeks |
| 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. | Baseline, 54 weeks |
| 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. | Baseline, 66 weeks |
| 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. | Baseline, 78 weeks |
| Scottsdale |
| Arizona |
| 85259-5499 |
| United States |
| University of Southern California Keck School of Medicine | Los Angeles | California | 90033-1026 | United States |
| UC Davis Medical Center | Sacramento | California | 95817 | United States |
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
| Oschner Medical Center | Kenner | Louisiana | 70065 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| SUNY Downstate Medical Center | Brooklyn | New York | 11203 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Southwestern Regional Medical Center, Inc. | Tulsa | Oklahoma | 74133 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Allegheny Center for Digestive Health - AHN ASRI | Pittsburgh | Pennsylvania | 15212 | United States |
| Methodist Dallas Medical Center | Dallas | Texas | 75208 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington | 99204 | United States |
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| CHUM Hôpital St-Luc | Montreal | Quebec | H2X 3J4 | Canada |
| Klinikum Ludwigsburg | Ludwigsburg | Baden-Wurttemberg | 71640 | Germany |
| Klinikum Mannheim GmbH | Mannheim | Baden-Wurttemberg | 68167 | Germany |
| Johann-Wolfgang-Goethe Universität Frankfurt | Frankfurt am Main | Hesse | 60590 | Germany |
| Medizinische Hochschule Hannover | Hanover | Lower Saxony | 30625 | Germany |
| Universitätsklinikum Essen (AöR) | Essen | North Rhine-Westphalia | D-45147 | Germany |
| Konkuk University Medical Center | Seoul | Gwangjin-gu | 143-729 | South Korea |
| Soonchunhyang University Bucheon Hospital | Bucheon-si | Gyeonggi-do | 420-767 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | Seodaemun-gu | 120-752 | South Korea |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| UniversitätsSpital Zürich | Zurich | 8091 | Switzerland |
| FG001 | Standard Medical Care (SMC) | Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised 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 could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Photodynamic Therapy-Photofrin Plus SMC | Photodynamic therapy (PDT) involved the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) was applied to the tumor. A second light application was given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients underwent stenting. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) could be given at 3-month intervals. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. The chemotherapy regimen comprised 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 could be administered if there was no disease progression or intolerable toxicity. |
| BG001 | Standard Medical Care (SMC) | Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised 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 could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | All participants randomized (intent-to-treat population) | Posted | Median | 95% Confidence Interval | days | Up to 26 months |
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| Secondary | Time-to-bilirubin Response | From the date of randomization until the date of first documented bilirubin response | Data not collected | Posted | Up to 30 days |
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| Secondary | 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) | Due to the premature termination of the study, there was insufficient data to allow statistical analysis. | Posted | Number | percentage of participants | Up to 26 months |
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| Secondary | Time-to-tumor Progression | From the date of first documented response until the date that tumor progression was assessed | Not collected | Posted | Up to 26 months |
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| Secondary | 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. | At Day 7, all 15 subjects in the PDT +SMC group were analysed and 9/13 in the SMC Alone group were analysed. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 7 days |
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| Secondary | 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. | At 4 weeks, 12 subjects in the PDT +SMC group were analysed and 9 in the SMC Alone group were analysed. | Posted | Mean | Standard Deviation | score on a scale | Baseline, up to 4 weeks |
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| Secondary | 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. | At 13 weeks, 8 subjects in the PDT +SMC group were analysed and 8 in the SMC Alone group were analysed. Due to the premature termination of the study, there was insufficient data to allow statistical analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 13 weeks |
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| Secondary | 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. | At 16 weeks, 9 subjects in the PDT +SMC group were analysed and 9 in the SMC Alone group were analysed. Due to the premature termination of the study, there was insufficient data to allow statistical analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 16 weeks |
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| Secondary | 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. | At 29 weeks, 6 subjects in the PDT +SMC group were analysed and 5 in the SMC Alone group were analysed. Due to the premature termination of the study, there was insufficient data to allow statistical analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 29 weeks |
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| Secondary | 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. | At 41 weeks, 2 subjects in the PDT +SMC group were analysed and 1 in the SMC Alone group was analysed. Due to the premature termination of the study, there was insufficient data to allow statistical analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 41 weeks |
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| Secondary | 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. | At 54 weeks, only 1 subject in each group was measured. Due to the premature termination of the study, there was insufficient data to allow statistical analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 54 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Data not collected | Posted | Baseline, 66 weeks |
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| Secondary | 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. | Not collected | Posted | Baseline, 78 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | Due to the premature termination of the study, there was insufficient data to allow statistical analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 7 days |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Not collected | Posted | Baseline, up to 4 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | Due to the premature termination of the study, there was insufficient data to allow statistical analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 13 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Due to the premature termination of the study, there was insufficient data to allow statistical analysis. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Due to the premature termination of the study, there was insufficient data to allow statistical analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 29 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Due to the premature termination of the study, there was insufficient data to allow statistical analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 41 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Due to the premature termination of the study, there was insufficient data to allow statistical analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 54 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | No data collected | Posted | Baseline, 66 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | No data collected | Posted | Baseline, 78 weeks |
|
26 months
The SMC alone group enrolled 13 subjects but only 10 were treated thus there were only 10 subjects at risk for adverse events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Photodynamic Therapy-Photofrin Plus SMC | Photodynamic therapy (PDT) involved the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) was applied to the tumor. A second light application was given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients underwent stenting. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) could be given at 3-month intervals. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. The chemotherapy regimen comprised 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 could be administered if there was no disease progression or intolerable toxicity. | 1 | 15 | 11 | 15 | 13 | 15 |
| EG001 | Standard Medical Care (SMC) | Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised 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 could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. | 0 | 13 | 10 | 10 | 10 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Liver abcess | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Biloma | Hepatobiliary disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Haemobilia | Hepatobiliary disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hepatitis cholestatic | Hepatobiliary disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Post-procedural complications | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Cholangitis acute | Hepatobiliary disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Edema peripheral | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Cholangitis acute | Hepatobiliary disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hypokaliemia | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Iron deficiency anemia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Bilirubine increase | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| CA-19 increase | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| GGT | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Uretherolithiasis | Renal and urinary disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Nausea | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Skin cut | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Aplastic anemia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Splenic infarction | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Eustachian tube dysfunction | Ear and labyrinth disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Conjuctival hemorrhage | Eye disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Duodenal stenosis | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Feces discolored | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| GERD | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Small intestinal hemorrhage | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Catheter site discharge | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Catheter site injury | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Generalized edema | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Influenza-like illness | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Gallbladder perforation | Hepatobiliary disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Portal hypertension | Hepatobiliary disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Biliary tract infection bacteria | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Enterococcal bacteremia | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Procedural vomiting | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Skin wound | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| AST increased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hemoglobin decreased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| INR increased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pulse abnormal | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Fluid imbalance | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hyperkaliemia | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Vitamine D deficiency | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Asterixis | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hyperaesthesia | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Food aversion | Psychiatric disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Urethrolithiasis | Renal and urinary disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Tonsillar disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Upper airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pruritis generalized | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Rash erythmetous | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Solar lentigo | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
This study was prematurely terminated due to low accrual. Consequently, there was insufficient data to allow statistical analysis. Only descriptive statistics are presented for the primary endpoint, overall survival time.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michelle Depot | At the request of Concordia Laboratories Inc. | michelle.depot@advanzpharma.com |
| ID | Term |
|---|---|
| D018285 | Klatskin Tumor |
| D018281 | Cholangiocarcinoma |
| D001650 | Bile Duct Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D001661 | Biliary Tract Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| Germany |
|
|
Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised 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 could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. |
|
|
|
| OG001 |
| Standard Medical Care (SMC) |
Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised 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 could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. |
|
|
| OG001 |
| Standard Medical Care (SMC) |
Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised 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 could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. |
|
|
| OG001 | Standard Medical Care (SMC) | Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised 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 could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. |
|
|
| OG001 | Standard Medical Care (SMC) | Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised 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 could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. |
|
|
| OG001 | Standard Medical Care (SMC) | Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised 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 could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. |
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| OG001 | Standard Medical Care (SMC) | Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised 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 could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. |
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| OG001 | Standard Medical Care (SMC) | Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised 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 could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. |
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Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised 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 could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. |
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Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised 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 could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. |
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| OG001 | Standard Medical Care (SMC) | Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised 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 could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. |
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Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised 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 could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. |
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| OG001 |
| Standard Medical Care (SMC) |
Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised 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 could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. |
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| OG001 |
| Standard Medical Care (SMC) |
Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised 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 could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. |
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| OG001 |
| Standard Medical Care (SMC) |
Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised 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 could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. |
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| OG001 |
| Standard Medical Care (SMC) |
Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised 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 could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. |
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| OG001 |
| Standard Medical Care (SMC) |
Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised 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 could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. |
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Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised 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 could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. |
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Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised 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 could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. |
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