Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| HUM00098022 | Other Identifier | University of Michigan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a pilot single arm study with the primary endpoints of feasibility and preliminary estimates of safety and efficacy. This protocol builds on over 25 years of experience with high dose liver RT (Radiation Therapy), and in particular adaptive RT aimed at adjusting the global radiation dose based on a patient's measured sensitivity to treatment. This current protocol uses functional imaging and specialized radiation planning techniques to spare highly functional portions of the liver to preserve function. The investigators feel this will further improve the safety and efficacy of RT for all patients by customizing treatments to each. If this approach is promising, the investigators will proceed to a phase II randomized study of standard versus spatially and dosimetrically adapted RT.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adaptive Radiation Therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adaptive Radiation Therapy | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Patients for Whom the Intended Treatment Was Feasible | The primary aim of the trial is feasibility which is defined as the ability to successfully deliver the full treatment including all adaptations and in particular the perfusion-based planning and replanning. | At end of treatment; up to ~3 months |
| Percentage of Patients With Change in Child Pugh Score >= 2 | Rate of liver decompensation reported as the percentage of patients with a change in Child Pugh score of greater than or equal to 2 within 6 months of SBRT. | Baseline to approximately 6 months after initiation of SBRT |
| Median Time to Local Progression | The primary efficacy endpoint is local control, measured as the duration of time from start of treatment to time of progression of the treated (target) lesion(s). Patients with no evidence of local progression at the time of data analysis will be censored at the last date on which they were evaluated for local progression. Local progression will be summarized with Kaplan-Meier curves and reported with 95% confidence intervals. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Median Time to Progression | Defined as the duration of time from start of treatment to time of progression. | 24 months |
| Change in ALBI Scores | Liver decompensation assessed by change in ALBI score > 0.5 from baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Radiation Induced Liver Disease (RILD) | RILD is a rare but serious side effect that will be summarized if it occurs. | 24 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Theodore Lawrence, M.D., Ph.D. | Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rogel Comprehensive Cancer Center | Ann Arbor | Michigan | 48187 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Adaptive Radiation Therapy | Adaptive Radiation Therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Adaptive Radiation Therapy | Adaptive Radiation Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | The Proportion of Patients for Whom the Intended Treatment Was Feasible | The primary aim of the trial is feasibility which is defined as the ability to successfully deliver the full treatment including all adaptations and in particular the perfusion-based planning and replanning. | 77 subjects enrolled, 70 subjects treated | Posted | Count of Participants | Participants | At end of treatment; up to ~3 months |
|
|
All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 2 years after last dose of study treatment. Data was collected over 6 years.
Not provided
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 | Adaptive Radiation Therapy | Adaptive Radiation Therapy | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Theodore Lawrence | University of Michigan Rogel Cancer Center | 734-647-9955 | tsl@umich.edu |
Not provided
| 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 | Apr 30, 2020 | Oct 10, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 21, 2020 | Oct 10, 2023 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Approximately 6 months |
| Incidence of Grade 3 Gastrointestinal (GI) Bleeding Toxicities | Grade 3 GI bleeding assessed via the NCI CTCAE version 4.0. | Approximately 6 months |
| Overall Survival | Overall survival (OS) is defined as the duration of time from start of treatment to death. | 24 months |
| Withdrawal by Subject |
|
| Underwent fractionated RT |
|
| Unable to complete follow-up lab draws |
|
| Participants |
|
| Age, Continuous | Mean | 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 |
|
|
|
| Primary | Percentage of Patients With Change in Child Pugh Score >= 2 | Rate of liver decompensation reported as the percentage of patients with a change in Child Pugh score of greater than or equal to 2 within 6 months of SBRT. | 77 subjects enrolled, 70 subjects treated, 56 eligible for analysis (14 were excluded: 10- fractionated RT, 2- unable to complete follow up, 2- withdrew) | Posted | Count of Participants | Participants | Baseline to approximately 6 months after initiation of SBRT |
|
|
|
| Primary | Median Time to Local Progression | The primary efficacy endpoint is local control, measured as the duration of time from start of treatment to time of progression of the treated (target) lesion(s). Patients with no evidence of local progression at the time of data analysis will be censored at the last date on which they were evaluated for local progression. Local progression will be summarized with Kaplan-Meier curves and reported with 95% confidence intervals. | 77 subjects enrolled, 70 subjects treated, 9 eligible for analysis | Posted | Median | 95% Confidence Interval | Months | 24 months |
|
|
|
| Secondary | Median Time to Progression | Defined as the duration of time from start of treatment to time of progression. | 77 subjects enrolled, 70 subjects treated, 31 eligible for analysis | Posted | Median | 95% Confidence Interval | months | 24 months |
|
|
|
| Secondary | Change in ALBI Scores | Liver decompensation assessed by change in ALBI score > 0.5 from baseline. | 77 subjects enrolled, 70 subjects treated, 56 eligible for analysis (14 were excluded: 10- fractionated RT, 2- unable to complete follow up, 2- withdrew) | Posted | Count of Participants | Participants | Approximately 6 months |
|
|
|
| Secondary | Incidence of Grade 3 Gastrointestinal (GI) Bleeding Toxicities | Grade 3 GI bleeding assessed via the NCI CTCAE version 4.0. | 77 subjects enrolled, 70 subjects treated, 56 eligible for analysis (14 were excluded: 10- fractionated RT, 2- unable to complete follow up, 2- withdrew) | Posted | Count of Participants | Participants | Approximately 6 months |
|
|
|
| Secondary | Overall Survival | Overall survival (OS) is defined as the duration of time from start of treatment to death. | 77 subjects enrolled, 70 subjects treated, 54 eligible for analysis | Posted | Median | 95% Confidence Interval | Months | 24 months |
|
|
|
| Other Pre-specified | Incidence of Radiation Induced Liver Disease (RILD) | RILD is a rare but serious side effect that will be summarized if it occurs. | Not Posted | 24 months | Participants |
| 77 |
| 6 |
| 77 |
| 67 |
| 77 |
| Acute Kidney Injury | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Catheter Related Infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Encephalopathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Heart failure | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Chills | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Edema Limbs | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Multi-organ Failure | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hepatic Pain | Hepatobiliary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Blood Bilirubin increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| dizziness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Encephalopathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Cystitis noninfective | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |