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| Name | Class |
|---|---|
| Ipsen | INDUSTRY |
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This is a phase II, single-arm, open-label, clinical study to investigate the efficacy and tolerability of a combination of liposomal irinotecan (nal-IRI) with oxaliplatin, leucovorin, and 5-fluorouracil (FOLFOX-nal-IRI) for treatment of patients with locally advanced pancreatic carcinoma (LAPC).
This is a phase II, single-arm, open-label, clinical study to investigate the efficacy and tolerability of a combination of liposomal irinotecan (nal-IRI) with oxaliplatin, leucovorin, and 5-fluorouracil (FOLFOX-nal-IRI) for treatment of patients with locally advanced pancreatic carcinoma (LAPC). Each subject will be screened for eligibility by evaluation including medical history, physical examination, performance status, blood tests, computed tomographic (CT) scans, and electrocardiogram. Within 28 days of screening, the consented subjects will have a central venous access device placed and then start treatment.
For every 2-week cycle of FOLFOX-nal-IRI, each subject will receive nal-IRI (irinotecan free base 50 mg/m2 intravenously over 90 minutes), oxaliplatin (60 mg/m2 intravenously over 2 hours), leucovorin (400 mg/m2 intravenously over 2 hours), and 5-fluorouracil 2,400 mg/m2 intravenously over 46 hours).
Tumor response/surgical assessment will be evaluated after every 4 cycles of treatment with CT scans using RECIST 1.1 criteria. If the tumor becomes surgically resectable and the subject is a surgical candidate as determined by a multidisciplinary team, the subject will undergo surgery (at which point he/she would enter survival follow-up). If the tumor remains unresectable and there is no tumor progression, each subject will be treated up to a total of 12 cycles of FOLFOX-nal-IRI.
Following treatment with 12 cycles of FOLFOX-nal-IRI, if tumor remains unresectable, the subjects may receive further treatment (chemotherapy using the same regimen or of the treating physician's choice, or chemoradiation therapy) or observation as determined by the physician. During the course of treatment, if the subjects develop unacceptable toxicity and/or disease progression, the treatment will be discontinued, and the subjects will be further managed at the discretion of the treating oncologists.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FOLFOX + Irinotecan | Experimental | Oxaliplatin 60 mg/m2 Intravenously (IV) over 2 hours Liposomal Irinotecan (free base) 50 mg/m2 IV over 90 minutes after completion of oxaliplatin Leucovorin 400 mg/m2 IV over 30 minutes after completion of liposomal irinotecan 5-Fluorouracil 2,400 mg/m2 IV over 46 hours via infusion pump at home All drugs administered on day 1 of each 14 day cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FOLFOX regimen | Drug | FOLFOX (Oxaliplatin, Leucovorin, 5-Fluorouracil) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Disease Control Rate (DCR) = CR +PR+SD | Up to 22 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) at 8 Weeks | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Overall Response (OR) = CR + PR. |
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Inclusion Criteria:
Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Age ≥ 18 years at the time of consent.
ECOG Performance Status of 0-1 within 28 days prior to registration.
Histological or cytological confirmation of pancreatic carcinoma.
Measurable disease according to RECIST v1.1 within 28 days prior to registration.
Previously untreated pancreatic carcinoma considered as locally advanced unresectable according to NCCN guidelines.
Demonstrate adequate organ function as defined in the table below; All screening labs to be obtained within 14 days prior to initiation of study treatment.
Hematological
Renal
Hepatic
Coagulation ---International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT): \
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| Name | Affiliation | Role |
|---|---|---|
| Nelson Yee | Penn State Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States | ||
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | FOLFOX + Irinotecan | Oxaliplatin 60 mg/m2 Intravenously (IV) over 2 hours Liposomal Irinotecan (free base) 50 mg/m2 IV over 90 minutes after completion of oxaliplatin Leucovorin 400 mg/m2 IV over 30 minutes after completion of liposomal irinotecan 5-Fluorouracil 2,400 mg/m2 IV over 46 hours via infusion pump at home All drugs administered on day 1 of each 14 day cycle. FOLFOX regimen: FOLFOX (Oxaliplatin, Leucovorin, 5-Fluorouracil) Liposomal Irinotecan: Liposomal Irinotecan |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 12, 2022 |
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This is a phase II, single-arm, open-label, clinical study.
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| Liposomal Irinotecan |
| Drug |
Liposomal Irinotecan |
|
|
| 8 weeks |
| Objective Response Rate (ORR) at 16 Weeks | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Overall Response (OR) = CR + PR. | 16 weeks |
| Objective Response Rate (ORR) at 24 Weeks | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Overall Response (OR) = CR + PR. | 24 weeks |
| Stable Disease Rate (SDR) at 8 Weeks | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Stable disease rate (SDR) is determined by the proportion of subjects with no progression of disease as defined by RECIST 1.1, at 8 weeks following initiation of FOLFOX-nal-IRI. | 8 Weeks |
| Stable Disease Rate (SDR) at 16 Weeks | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Stable disease rate (SDR) as determined by the proportion of subjects with no progression of disease as defined by RECIST 1.1, at 16 weeks following initiation of FOLFOX-nal-IRI. | 16 Weeks |
| Stable Disease Rate (SDR) at 24 Weeks | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Stable disease rate (SDR) as determined by the proportion of subjects with no progression of disease as defined by RECIST 1.1, at 24 weeks following initiation of FOLFOX-nal-IRI. | 24 Weeks |
| Proportion of Subjects Able to Undergo Surgical Resection | Rate of resectability as determined by the proportion of subjects who undergo surgical resection of tumors. | 12 months |
| Response of Serum CA19-9 Levels | A CA 19-9 test measures the amount of a protein called CA19-9 (cancer antigen 19-9) in a sample of blood. Healthy people can have small amounts of CA 19-9 in their blood. High levels of CA 19-9 are often a sign of pancreatic cancer. Increasing CA 19-9 levels mean the tumor is growing, whether decreasing CA 19-9 levels may mean the tumor is shrinking. The Mean of the percentage change from baseline in serum CA19-9 levels associated with best confirmed response (PR, SD, PD) per RECIST 1.1 are reported in the outcome measure data table. | Up to 7 months |
| Progression-Free Survival (PFS) | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Progression-free survival (PFS) as determined by the time interval from the date of first dose of study drug to first documented disease progression or death from any cause, whichever occurs first. | Up to 22 months |
| Overall Survival (OS) | Overall survival (OS) is defined as time from the first dose of study drug to date of death from any cause. | Up to 31 months |
| Number of Participants With Adverse Events | Adverse events will be assessed to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 5. | Up to 7 months |
| Quality of Life (QoL) Assessment: Global Health Status (EORTC QLQ-C30) | This secondary outcome measure evaluates overall quality of life using the Global Health Status scale from the EORTC QLQ-C30. Scores range from 0 to 100, with higher scores indicating better global health and quality of life. Mean (SD) scores are reported by assessment period, including only those participants who reached the defined time points (e.g., Cycle 9). | Treatment Cycle 1 (14 days), Treatment Cycle 5 (70 days), Treatment Cycle 9 (126 days), Follow-Up (7 Months) |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Rutgers Cancer Institute of new Jersey | New Brunswick | New Jersey | 08903 | United States |
| Penn State Cancer Institute | Hershey | Pennsylvania | 17033 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FOLFOX + Irinotecan | Oxaliplatin 60 mg/m2 Intravenously (IV) over 2 hours Liposomal Irinotecan (free base) 50 mg/m2 IV over 90 minutes after completion of oxaliplatin Leucovorin 400 mg/m2 IV over 30 minutes after completion of liposomal irinotecan 5-Fluorouracil 2,400 mg/m2 IV over 46 hours via infusion pump at home All drugs administered on day 1 of each 14 day cycle. FOLFOX regimen: FOLFOX (Oxaliplatin, Leucovorin, 5-Fluorouracil) Liposomal Irinotecan: Liposomal Irinotecan |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Disease Control Rate (DCR) | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Disease Control Rate (DCR) = CR +PR+SD | In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Disease Control Rate was defined as all participants who received at least one dose of trial drug and undergo at least one post-baseline disease assessment. | Posted | Number | Percentage of participants | Up to 22 months |
|
|
| ||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) at 8 Weeks | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Overall Response (OR) = CR + PR. | All participants who have disease assessment at 8 weeks. | Posted | Number | Percentage of participants | 8 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) at 16 Weeks | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Overall Response (OR) = CR + PR. | All participants who have disease assessment at 16 weeks. | Posted | Number | Percentage of participants | 16 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) at 24 Weeks | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Overall Response (OR) = CR + PR. | All participants who have disease assessment at 24 weeks. | Posted | Number | Percentage of participants | 24 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Stable Disease Rate (SDR) at 8 Weeks | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Stable disease rate (SDR) is determined by the proportion of subjects with no progression of disease as defined by RECIST 1.1, at 8 weeks following initiation of FOLFOX-nal-IRI. | All participants who have disease assessment at 8 weeks. | Posted | Number | Percentage of participants | 8 Weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Stable Disease Rate (SDR) at 16 Weeks | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Stable disease rate (SDR) as determined by the proportion of subjects with no progression of disease as defined by RECIST 1.1, at 16 weeks following initiation of FOLFOX-nal-IRI. | All participants who have disease assessment at 16 weeks. | Posted | Number | Percentage of participants | 16 Weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Stable Disease Rate (SDR) at 24 Weeks | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Stable disease rate (SDR) as determined by the proportion of subjects with no progression of disease as defined by RECIST 1.1, at 24 weeks following initiation of FOLFOX-nal-IRI. | All participants who have disease assessment at 24 weeks. | Posted | Number | Percentage of participants | 24 Weeks |
|
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| Secondary | Proportion of Subjects Able to Undergo Surgical Resection | Rate of resectability as determined by the proportion of subjects who undergo surgical resection of tumors. | Out of 28 subjects, only 21 subjects had information for surgical resection. | Posted | Number | Proportion of participants | 12 months |
|
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| Secondary | Response of Serum CA19-9 Levels | A CA 19-9 test measures the amount of a protein called CA19-9 (cancer antigen 19-9) in a sample of blood. Healthy people can have small amounts of CA 19-9 in their blood. High levels of CA 19-9 are often a sign of pancreatic cancer. Increasing CA 19-9 levels mean the tumor is growing, whether decreasing CA 19-9 levels may mean the tumor is shrinking. The Mean of the percentage change from baseline in serum CA19-9 levels associated with best confirmed response (PR, SD, PD) per RECIST 1.1 are reported in the outcome measure data table. | All participants who received at least one dose of trial drug, undergo at least one post-baseline disease assessment, and have post-baseline serum CA19-9 information. | Posted | Mean | Standard Deviation | Percentage Change from Baseline | Up to 7 months |
|
| ||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Progression-free survival (PFS) as determined by the time interval from the date of first dose of study drug to first documented disease progression or death from any cause, whichever occurs first. | In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Progression-Free Survival was defined as all participants who received at least one dose of trial drug and either undergo at least one post-baseline disease assessment or die before any evaluation. | Posted | Median | 95% Confidence Interval | Months | Up to 22 months |
| |||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall survival (OS) is defined as time from the first dose of study drug to date of death from any cause. | In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Overall Survival was defined as all participants who received at least one dose of trial drug and either undergo at least one post-baseline disease assessment or die before any evaluation. | Posted | Median | 95% Confidence Interval | Months | Up to 31 months |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events | Adverse events will be assessed to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 5. | The analysis population for Adverse Events was defined as all patients who received at least one dose of study treatment regardless of the dosage. | Posted | Count of Participants | Participants | Up to 7 months |
|
| |||||||||||||||||||||||||||
| Secondary | Quality of Life (QoL) Assessment: Global Health Status (EORTC QLQ-C30) | This secondary outcome measure evaluates overall quality of life using the Global Health Status scale from the EORTC QLQ-C30. Scores range from 0 to 100, with higher scores indicating better global health and quality of life. Mean (SD) scores are reported by assessment period, including only those participants who reached the defined time points (e.g., Cycle 9). | All participants who reached the specified assessment time points (e.g., Cycle 9) were included in this outcome measure (Total 14 subjects). 13 out of these 14 subjects had information at treatment cycle 1, 12 out of these 14 subjects had information at treatment cycle 5, and 12 out of these 14 subjects had information at Follow-Up. | Posted | Mean | Standard Deviation | score on a scale | Treatment Cycle 1 (14 days), Treatment Cycle 5 (70 days), Treatment Cycle 9 (126 days), Follow-Up (7 Months) |
|
|
Up to maximum 31 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FOLFOX + Irinotecan | Oxaliplatin 60 mg/m2 Intravenously (IV) over 2 hours Liposomal Irinotecan (free base) 50 mg/m2 IV over 90 minutes after completion of oxaliplatin Leucovorin 400 mg/m2 IV over 30 minutes after completion of liposomal irinotecan 5-Fluorouracil 2,400 mg/m2 IV over 46 hours via infusion pump at home All drugs administered on day 1 of each 14 day cycle. FOLFOX regimen: FOLFOX (Oxaliplatin, Leucovorin, 5-Fluorouracil) Liposomal Irinotecan: Liposomal Irinotecan | 13 | 28 | 15 | 28 | 28 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | CTCAEv5 | Non-systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | CTCAEv5 | Non-systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | CTCAEv5 | Non-systematic Assessment |
| |
| BILIARY TRACT INFECTION | Infections and infestations | CTCAEv5 | Non-systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | CTCAEv5 | Non-systematic Assessment |
| |
| DIARRHEA | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| ENTEROCOLITIS | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| ENTEROCOLITIS INFECTIOUS | Infections and infestations | CTCAEv5 | Non-systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | CTCAEv5 | Non-systematic Assessment |
| |
| GALLBLADDER INFECTION | Infections and infestations | CTCAEv5 | Non-systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HEPATOBILIARY DISORDERS - OTHER, SPECIFY | Hepatobiliary disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPOMAGNESEMIA | Metabolism and nutrition disorders | CTCAEv5 | Non-systematic Assessment |
| |
| INFECTIONS AND INFESTATIONS - OTHER, SPECIFY | Infections and infestations | CTCAEv5 | Non-systematic Assessment |
| |
| LUNG INFECTION | Infections and infestations | CTCAEv5 | Non-systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | CTCAEv5 | Non-systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | CTCAEv5 | Non-systematic Assessment |
| |
| VENTRICULAR TACHYCARDIA | Cardiac disorders | CTCAEv5 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL DISTENSION | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | CTCAEv5 | Non-systematic Assessment |
| |
| AGITATION | Psychiatric disorders | CTCAEv5 | Non-systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | CTCAEv5 | Non-systematic Assessment |
| |
| ALKALINE PHOSPHATASE INCREASED | Investigations | CTCAEv5 | Non-systematic Assessment |
| |
| ALLERGIC RHINITIS | Respiratory, thoracic and mediastinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| ANEMIA | Blood and lymphatic system disorders | CTCAEv5 | Non-systematic Assessment |
| |
| ANOREXIA | Metabolism and nutrition disorders | CTCAEv5 | Non-systematic Assessment |
| |
| ANOSMIA | Nervous system disorders | CTCAEv5 | Non-systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | CTCAEv5 | Non-systematic Assessment |
| |
| ARTHRITIS | Musculoskeletal and connective tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | CTCAEv5 | Non-systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | CTCAEv5 | Non-systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| BACTEREMIA | Infections and infestations | CTCAEv5 | Non-systematic Assessment |
| |
| BELCHING | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| BLOATING | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| BLOOD BILIRUBIN INCREASED | Investigations | CTCAEv5 | Non-systematic Assessment |
| |
| BLURRED VISION | Eye disorders | CTCAEv5 | Non-systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| CARDIAC DISORDERS - OTHER, SPECIFY | Cardiac disorders | CTCAEv5 | Non-systematic Assessment |
| |
| CATARACT | Eye disorders | CTCAEv5 | Non-systematic Assessment |
| |
| CHILLS | General disorders | CTCAEv5 | Non-systematic Assessment |
| |
| CHOLESTEROL HIGH | Investigations | CTCAEv5 | Non-systematic Assessment |
| |
| CHRONIC KIDNEY DISEASE | Renal and urinary disorders | CTCAEv5 | Non-systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| CONFUSION | Psychiatric disorders | CTCAEv5 | Non-systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| CREATININE INCREASED | Investigations | CTCAEv5 | Non-systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | CTCAEv5 | Non-systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | CTCAEv5 | Non-systematic Assessment |
| |
| DIARRHEA | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | CTCAEv5 | Non-systematic Assessment |
| |
| DRY EYE | Eye disorders | CTCAEv5 | Non-systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| DYSESTHESIA | Nervous system disorders | CTCAEv5 | Non-systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | CTCAEv5 | Non-systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| DYSPNEA | Respiratory, thoracic and mediastinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| DYSURIA | Renal and urinary disorders | CTCAEv5 | Non-systematic Assessment |
| |
| ECZEMA | Skin and subcutaneous tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| EDEMA LIMBS | General disorders | CTCAEv5 | Non-systematic Assessment |
| |
| ENDOCRINE DISORDERS - OTHER, SPECIFY | Endocrine disorders | CTCAEv5 | Non-systematic Assessment |
| |
| ENTEROCOLITIS INFECTIOUS | Infections and infestations | CTCAEv5 | Non-systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| ERECTILE DYSFUNCTION | Reproductive system and breast disorders | CTCAEv5 | Non-systematic Assessment |
| |
| EYE DISORDERS - OTHER, SPECIFY | Eye disorders | CTCAEv5 | Non-systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | CTCAEv5 | Non-systematic Assessment |
| |
| FATIGUE | General disorders | CTCAEv5 | Non-systematic Assessment |
| |
| FEVER | General disorders | CTCAEv5 | Non-systematic Assessment |
| |
| FLANK PAIN | Musculoskeletal and connective tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| FLATULENCE | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| FLOATERS | Eye disorders | CTCAEv5 | Non-systematic Assessment |
| |
| FLUSHING | Vascular disorders | CTCAEv5 | Non-systematic Assessment |
| |
| FUNGEMIA | Infections and infestations | CTCAEv5 | Non-systematic Assessment |
| |
| GALLBLADDER INFECTION | Infections and infestations | CTCAEv5 | Non-systematic Assessment |
| |
| GASTROESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| GASTROINTESTINAL DISORDERS - OTHER, SPECIFY | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY | General disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HEADACHE | Nervous system disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HEART FAILURE | Cardiac disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HEMATURIA | Renal and urinary disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HEMORRHOIDS | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HERPES SIMPLEX REACTIVATION | Infections and infestations | CTCAEv5 | Non-systematic Assessment |
| |
| HICCUPS | Respiratory, thoracic and mediastinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPERGLYCEMIA | Metabolism and nutrition disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPERKALEMIA | Metabolism and nutrition disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPERLIPIDEMIA | Metabolism and nutrition disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPERNATREMIA | Metabolism and nutrition disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPOALBUMINEMIA | Metabolism and nutrition disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPOCALCEMIA | Metabolism and nutrition disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPOKALEMIA | Metabolism and nutrition disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPOMAGNESEMIA | Metabolism and nutrition disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPONATREMIA | Metabolism and nutrition disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPOPHOSPHATEMIA | Metabolism and nutrition disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | CTCAEv5 | Non-systematic Assessment |
| |
| HYPOTHYROIDISM | Endocrine disorders | CTCAEv5 | Non-systematic Assessment |
| |
| ILEUS | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| IMMUNE SYSTEM DISORDERS - OTHER, SPECIFY | Immune system disorders | CTCAEv5 | Non-systematic Assessment |
| |
| INFECTIONS AND INFESTATIONS - OTHER, SPECIFY | Infections and infestations | CTCAEv5 | Non-systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | CTCAEv5 | Non-systematic Assessment |
| |
| INVESTIGATIONS - OTHER, SPECIFY | Investigations | CTCAEv5 | Non-systematic Assessment |
| |
| LEUKOCYTOSIS | Blood and lymphatic system disorders | CTCAEv5 | Non-systematic Assessment |
| |
| LOCALIZED EDEMA | General disorders | CTCAEv5 | Non-systematic Assessment |
| |
| LOWER GASTROINTESTINAL HEMORRHAGE | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| LYMPHOCYTE COUNT DECREASED | Investigations | CTCAEv5 | Non-systematic Assessment |
| |
| METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIFY | Metabolism and nutrition disorders | CTCAEv5 | Non-systematic Assessment |
| |
| MUCOSITIS ORAL | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| MUSCLE CRAMP | Musculoskeletal and connective tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY | Musculoskeletal and connective tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAEv5 | Non-systematic Assessment |
| |
| NERVOUS SYSTEM DISORDERS - OTHER, SPECIFY | Nervous system disorders | CTCAEv5 | Non-systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | CTCAEv5 | Non-systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | CTCAEv5 | Non-systematic Assessment |
| |
| OBESITY | Metabolism and nutrition disorders | CTCAEv5 | Non-systematic Assessment |
| |
| ORAL PAIN | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| PAIN | General disorders | CTCAEv5 | Non-systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| PARESTHESIA | Nervous system disorders | CTCAEv5 | Non-systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | CTCAEv5 | Non-systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | CTCAEv5 | Non-systematic Assessment |
| |
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| PROSTATIC OBSTRUCTION | Reproductive system and breast disorders | CTCAEv5 | Non-systematic Assessment |
| |
| PSYCHOSIS | Psychiatric disorders | CTCAEv5 | Non-systematic Assessment |
| |
| RADICULITIS | Nervous system disorders | CTCAEv5 | Non-systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| RECTAL FISSURE | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| RECTAL PAIN | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY | Respiratory, thoracic and mediastinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| RHINORRHEA | Respiratory, thoracic and mediastinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| SEIZURE | Nervous system disorders | CTCAEv5 | Non-systematic Assessment |
| |
| SINUS BRADYCARDIA | Cardiac disorders | CTCAEv5 | Non-systematic Assessment |
| |
| SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY | Skin and subcutaneous tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| SKIN HYPERPIGMENTATION | Skin and subcutaneous tissue disorders | CTCAEv5 | Non-systematic Assessment |
| |
| SKIN INFECTION | Infections and infestations | CTCAEv5 | Non-systematic Assessment |
| |
| SLEEP APNEA | Respiratory, thoracic and mediastinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| SOCIAL CIRCUMSTANCES - OTHER, SPECIFY | Social circumstances | CTCAEv5 | Non-systematic Assessment |
| |
| STRIDOR | Respiratory, thoracic and mediastinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY | Surgical and medical procedures | CTCAEv5 | Non-systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | CTCAEv5 | Non-systematic Assessment |
| |
| TESTICULAR DISORDER | Reproductive system and breast disorders | CTCAEv5 | Non-systematic Assessment |
| |
| TESTOSTERONE DEFICIENCY | Endocrine disorders | CTCAEv5 | Non-systematic Assessment |
| |
| THROMBOEMBOLIC EVENT | Vascular disorders | CTCAEv5 | Non-systematic Assessment |
| |
| TREMOR | Nervous system disorders | CTCAEv5 | Non-systematic Assessment |
| |
| TUMOR PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAEv5 | Non-systematic Assessment |
| |
| UPPER GASTROINTESTINAL HEMORRHAGE | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| UPPER RESPIRATORY INFECTION | Infections and infestations | CTCAEv5 | Non-systematic Assessment |
| |
| URINARY TRACT OBSTRUCTION | Renal and urinary disorders | CTCAEv5 | Non-systematic Assessment |
| |
| URINARY TRACT PAIN | Renal and urinary disorders | CTCAEv5 | Non-systematic Assessment |
| |
| VASCULAR DISORDERS - OTHER, SPECIFY | Vascular disorders | CTCAEv5 | Non-systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | CTCAEv5 | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| WEIGHT LOSS | Investigations | CTCAEv5 | Non-systematic Assessment |
| |
| WHEEZING | Respiratory, thoracic and mediastinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| WHITE BLOOD CELL DECREASED | Investigations | CTCAEv5 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fauzia Sharmin | Hoosier Cancer Research Network | 317-921-2050 | fsharmin@hoosiercancer.org |
| Dec 6, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| C410216 | Folfox protocol |
| C584112 | irinotecan sucrosofate |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Counts |
|---|
| Participants |
|
|