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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00029467 | Other Identifier | University of Michigan Medical IRB |
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This is a Phase II trial to characterize the safety and efficacy of individualized stereotactic body radiation therapy (SRBT) for patients who have had previous liver treatment or who have primary hepatocellular carcinoma (HCC).
The trial endpoints are toxicity, survival and progression-free survival. DCE-MRI and plasma biomarkers will also be collected to explore their use as tools for treatment individualization in future trials. During the current trial, an indicator of liver function, indocyanine green (ICG), will be used to identify during treatment patients who are at excess risk for radiation-induced liver disease (RILD) so that their radiation dose may be reduced. The model used for individualization will be updated as trial data accrue, so this is an adaptive trial of an individualized therapy. The planned accrual is seventy (70) evaluable patients over three years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liver cancer patients | Experimental | The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| individualized Stereotactic Body Radiation Therapy (SBRT) | Radiation | The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Patients With Local Control at 1 Year Post Treatment | For this study, local control is defined as the lack of progressive local disease following CR (Complete Response) or PR (Partial Response), or lack of progressive local disease in patients with non-evaluable disease, who have no progressive elevation in serum tumor markers. | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Patients Alive Without Progression at 1 Year | Progression is defined as a greater than or equal to 20% growth of a lesion from the smallest lesion measurement | 1 Year |
| The Percentage of Patients Alive at 1 Year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyle Cuneo, MD | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109-5010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28796864 | Derived | Feng M, Suresh K, Schipper MJ, Bazzi L, Ben-Josef E, Matuszak MM, Parikh ND, Welling TH, Normolle D, Ten Haken RK, Lawrence TS. Individualized Adaptive Stereotactic Body Radiotherapy for Liver Tumors in Patients at High Risk for Liver Damage: A Phase 2 Clinical Trial. JAMA Oncol. 2018 Jan 1;4(1):40-47. doi: 10.1001/jamaoncol.2017.2303. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Liver Cancer Patients | The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC). individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Liver Cancer Patients | The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC). individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The Percentage of Patients With Local Control at 1 Year Post Treatment | For this study, local control is defined as the lack of progressive local disease following CR (Complete Response) or PR (Partial Response), or lack of progressive local disease in patients with non-evaluable disease, who have no progressive elevation in serum tumor markers. | Posted | Number | 95% Confidence Interval | percentage of patients | 1 Year |
|
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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 | Liver Cancer Patients | The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC). individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sick sinus syndrome | Cardiac disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kyle Cuneo, M.D. | University of Michigan Comprehensive Cancer Center | 734-936-4300 | kcuneo@umich.edu |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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|
| 1 Year |
| The Number of Patients Who Experience Grade 4+ Hepatotoxicity | Grade 4 toxicities are life threatening toxicities that require urgent attention. | 1 Year |
| The Number of Patients That Experience Grade 4+ Gastrointestinal Bleeding | Grade 4 toxicities are life threatening toxicities that require urgent attention. | 1 Year |
| years |
|
| Gender | Count of Participants | Participants |
|
|
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| Secondary | The Percentage of Patients Alive Without Progression at 1 Year | Progression is defined as a greater than or equal to 20% growth of a lesion from the smallest lesion measurement | Posted | Number | 95% Confidence Interval | percentage of patients | 1 Year |
|
|
|
| Secondary | The Percentage of Patients Alive at 1 Year | Posted | Number | 95% Confidence Interval | percentage of patients | 1 Year |
|
|
|
| Secondary | The Number of Patients Who Experience Grade 4+ Hepatotoxicity | Grade 4 toxicities are life threatening toxicities that require urgent attention. | Posted | Number | patients | 1 Year |
|
|
|
| Secondary | The Number of Patients That Experience Grade 4+ Gastrointestinal Bleeding | Grade 4 toxicities are life threatening toxicities that require urgent attention. | Posted | Number | patients | 1 Year |
|
|
|
| 22 |
| 146 |
| 81 |
| 146 |
| Atrial fibrillation | Cardiac disorders |
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| Chest pain - cardiac | Cardiac disorders |
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| Heart failure | Cardiac disorders |
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| Myocardial infarction | Cardiac disorders |
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| Diarrhea | Gastrointestinal disorders |
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| Esophageal varices hemorrhage | Gastrointestinal disorders |
|
| Pancreatitis | Gastrointestinal disorders |
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| Vomiting | Gastrointestinal disorders |
|
| Chills | General disorders |
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| Multi-organ failure | General disorders |
|
| Cholecystitis | Hepatobiliary disorders |
|
| Sepsis | Infections and infestations |
|
| Urinary tract infection | Infections and infestations |
|
| Fall | Injury, poisoning and procedural complications |
|
| Blood bilirubin increased | Investigations |
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| Dehydration | Metabolism and nutrition disorders |
|
| Hyperglycemia | Metabolism and nutrition disorders |
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| Metabolism and nutrition disorders - Other | Metabolism and nutrition disorders |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders |
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| Encephalopathy | Nervous system disorders |
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| Renal and urinary disorders - Other | Renal and urinary disorders |
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| Urinary retention | Renal and urinary disorders |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders |
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| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders |
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| Social circumstances - Other | Social circumstances |
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| Hypotension | Vascular disorders |
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| Abdominal pain | Gastrointestinal disorders |
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| Gastrointestinal disorders - Other | Gastrointestinal disorders |
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| Nausea | Gastrointestinal disorders |
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| Upper gastrointestinal hemorrhage | Gastrointestinal disorders |
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| Fatigue | General disorders |
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| Fever | General disorders |
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| Lung infection | Infections and infestations |
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| Psychiatric disorders - Other | Psychiatric disorders |
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| Acute kidney injury | Renal and urinary disorders |
|
| Thromboembolic event | Vascular disorders |
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| Ascites | Gastrointestinal disorders |
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| Hepatobiliary disorders - Other | Hepatobiliary disorders |
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| Sinus tachycardia | Cardiac disorders |
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| Ear and labyrinth disorders - Other | Ear and labyrinth disorders |
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| Tinnitus | Ear and labyrinth disorders |
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| Blurred vision | Eye disorders |
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| Abdominal distension | Gastrointestinal disorders |
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| Bloating | Gastrointestinal disorders |
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| Dyspepsia | Gastrointestinal disorders |
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| Esophagitis | Gastrointestinal disorders |
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| Gastritis | Gastrointestinal disorders |
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| Oral pain | Gastrointestinal disorders |
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| Edema limbs | General disorders |
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| General disorders and administration site conditions - Other | General disorders |
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| Non-cardiac chest pain | General disorders |
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| Pain | General disorders |
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| Hepatic failure | Hepatobiliary disorders |
|
| Hepatic pain | Hepatobiliary disorders |
|
| Portal vein thrombosis | Hepatobiliary disorders |
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| Alanine aminotransferase increased | Investigations |
|
| Alkaline phosphatase increased | Investigations |
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| Aspartate aminotransferase increased | Investigations |
|
| CD4 lymphocytes decreased | Investigations |
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| Creatinine increased | Investigations |
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| INR increased | Investigations |
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| Lipase increased | Investigations |
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| Lymphocyte count decreased | Investigations |
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| Neutrophil count decreased | Investigations |
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| Platelet count decreased | Investigations |
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| Serum amylase increased | Investigations |
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| White blood cell decreased | Investigations |
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| Acidosis | Metabolism and nutrition disorders |
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| Anorexia | Metabolism and nutrition disorders |
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| Hyperkalemia | Metabolism and nutrition disorders |
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| Hypoalbuminemia | Metabolism and nutrition disorders |
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| Hypocalcemia | Metabolism and nutrition disorders |
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| Hypoglycemia | Metabolism and nutrition disorders |
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| Hyponatremia | Metabolism and nutrition disorders |
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| Musculoskeletal and connective tissue disorder - Other | Musculoskeletal and connective tissue disorders |
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| Neck pain | Musculoskeletal and connective tissue disorders |
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| Pain in extremity | Musculoskeletal and connective tissue disorders |
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| Ataxia | Nervous system disorders |
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| Depressed level of consciousness | Nervous system disorders |
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| Dizziness | Nervous system disorders |
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| Dysarthria | Nervous system disorders |
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| Dysgeusia | Nervous system disorders |
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| Peripheral sensory neuropathy | Nervous system disorders |
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| Seizure | Nervous system disorders |
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| Syncope | Nervous system disorders |
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| Anxiety | Psychiatric disorders |
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| Confusion | Psychiatric disorders |
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| Depression | Psychiatric disorders |
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| Personality change | Psychiatric disorders |
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| Hematuria | Renal and urinary disorders |
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| Urine discoloration | Renal and urinary disorders |
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| Erectile dysfunction | Reproductive system and breast disorders |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders |
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| Hiccups | Respiratory, thoracic and mediastinal disorders |
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| Hoarseness | Respiratory, thoracic and mediastinal disorders |
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| Dry skin | Skin and subcutaneous tissue disorders |
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| Pruritus | Skin and subcutaneous tissue disorders |
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| Skin and subcutaneous tissue disorders - Other | Skin and subcutaneous tissue disorders |
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| Hypertension | Vascular disorders |
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| Anemia | Blood and lymphatic system disorders |
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| Diarrhea | Gastrointestinal disorders |
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| Vomiting | Gastrointestinal disorders |
|
| Chills | General disorders |
|
| Urinary tract infection | Infections and infestations |
|
| Blood bilirubin increased | Investigations |
|
| Dehydration | Metabolism and nutrition disorders |
|
| Hyperglycemia | Metabolism and nutrition disorders |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders |
|
| Encephalopathy | Nervous system disorders |
|
| Renal and urinary disorders - Other | Renal and urinary disorders |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders |
|
| Abdominal pain | Gastrointestinal disorders |
|
| Gastrointestinal disorders - Other | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Fatigue | General disorders |
|
| Fever | General disorders |
|
| Psychiatric disorders - Other | Psychiatric disorders |
|
| Acute kidney injury | Renal and urinary disorders |
|
| Thromboembolic event | Vascular disorders |
|
| Ascites | Gastrointestinal disorders |
|
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| D008107 |
| Liver Diseases |