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The purpose of this study is to compare radiation treatment plans that are designed for patients with liver cancer. One treatment plan will be created using routine procedures and scans normally performed for radiation treatment planning. The other treatment plan will be created using routine procedures with the addition of two imaging scans; a HIDA (Hepatobiliary Iminodiacetic Acid) scan and an MRI (Magnetic Resonance Imaging) scan. This study will evaluate if adding these imaging scans to treatment planning can reduce the amount of radiation to healthy liver tissue during treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Theragnostic SBRT Planning | Experimental | The theragnostic SBRT plan using the HIDA scan was chosen as the plan that reduced the dose of radiation to functional liver without compromising target coverage or tumor control. |
|
| Standard SBRT Planning | No Intervention | The standard SBRT plan was chosen as the plan that reduced the dose of radiation to functional liver without compromising target coverage or tumor control. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hepatobiliary Iminodiacetic Acid (HIDA) scan | Diagnostic Test | HIDA scan was used as the planning scan for SBRT. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Functional Reserve of Liver Between Theragnostic SBRT Planning and Standard SBRT Planning | The functional reserve of the liver for both standard SBRT planning and theragnostic SBRT planning will be calculated for each patient regardless of which plan was ultimately chosen. Function reserve of the liver = (number of counts outside 15 Gy isodose line / total number of counts within the liver) * global liver function; where global liver function is the rate of liver uptake (%/min) between 150 to 300 seconds normalized to body surface area (m^2) using the Du Bois method. The difference in functional reserve between the theragnostic plan and the standard plan was calculated for each patient. | Day -1 of Radiation Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants for Whom Theragnostically Planned Radiation is Chosen for the Radiation Treatment Plan | The percentage of participants for whom theragnostically planned radiation is chosen for the radiation treatment plan over the standard plan will be calculated along with the corresponding exact 95% Binomial confidence interval. | Day -1 of Radiation Treatment |
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Inclusion Criteria
Subjects must be ≥ 18 years of age at the time of signing informed consent
Diagnosis of primary liver malignancy (including hepatocellular carcinoma [HCC] or cholangiocarcinoma) or liver metastasis from any primary solid tumor site by characteristic imaging findings on CT or MRI, clinical presentation, and/or pathologic confirmation of diagnosis.
Subjects with other current or prior malignancies are eligible for this study.
Patients with liver metastases must have at least one of the following clinical factors that may affect liver function:
ECOG (Zubrod) Performance Status 0-2.
Subjects must have a Child-Turcotte-Pugh (CTP) score ≤ 7 to be eligible.
Patients who have been previously treated with non-SBRT liver directed therapies may be enrolled on study. At least 3 months must have elapsed between the most recent liver-directed therapy and study entry.
Ability to provide written informed consent and HIPAA authorization
Subjects with an allergy to contrast agents may be enrolled at the treating physician's discretion with appropriate pre-treatment and symptom management.
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Ryan M Rhome, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Melvin & Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Theragnostic SBRT Planning | The theragnostic SBRT plan using the HIDA scan was chosen as the plan that reduced the dose of radiation to functional liver without compromising target coverage or tumor control. |
| FG001 | Standard SBRT Planning | The standard SBRT plan was chosen as the plan that reduced the dose of radiation to functional liver without compromising target coverage or tumor control. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Theragnostic SBRT Planning | The theragnostic SBRT plan using the HIDA scan was chosen as the plan that reduced the dose of radiation to functional liver without compromising target coverage or tumor control. |
| BG001 | Standard SBRT Planning |
| 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 | Difference in Functional Reserve of Liver Between Theragnostic SBRT Planning and Standard SBRT Planning | The functional reserve of the liver for both standard SBRT planning and theragnostic SBRT planning will be calculated for each patient regardless of which plan was ultimately chosen. Function reserve of the liver = (number of counts outside 15 Gy isodose line / total number of counts within the liver) * global liver function; where global liver function is the rate of liver uptake (%/min) between 150 to 300 seconds normalized to body surface area (m^2) using the Du Bois method. The difference in functional reserve between the theragnostic plan and the standard plan was calculated for each patient. | Patients who received at least one dose of radiation and completed both SBRT planning schemes. | Posted | Mean | Standard Deviation | %/min/m^2 | Day -1 of Radiation Treatment |
|
Up to 2 years
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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 | Theragnostic SBRT Planning | The theragnostic SBRT plan using the HIDA scan was chosen as the plan that reduced the dose of radiation to functional liver without compromising target coverage or tumor control. |
| 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ryan Rhome | IndianaU | (317) 944-1367 | rrhome@iu.edu |
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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 | Jul 9, 2020 | Oct 8, 2020 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 25, 2019 | Feb 23, 2021 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D011877 | Radionuclide Imaging |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003947 | Diagnostic Techniques, Radioisotope |
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| Duration of Local Control | Duration of local control was assessed by calculating the time from on study date to date of local failure. Patients who did not experience local failure were censored at their last evaluation date. Local failure (progressive disease at primary diagnosis site) was evaluated using RECIST v1.1 criteria: Complete response: Disappearance of all target lesions; Partial response: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. The Kaplan-Meier method was used to determine the median and 95% confidence interval. | Up to 15 months |
| Progression Free Survival | Progression free survival was defined as the time from on study date to date of recurrence of any type or death from any cause. Patients who did not experience recurrence or death were censored at their last evaluation date. The Kaplan-Meier method was used to determine the median and 95% confidence interval. | Up to 15 months |
| Overall Survival | Overall survival was defined as the time from on study date to death due to any cause. Patients who remained alive were censored at their last known alive date. The Kaplan-Meier method was used to determine the median and 95% confidence interval. | Up to 3 years |
| Time to Transplant | Time to transplant was defined as the time from on study date to the date of transplant. Patients who did not receive transplant were censored at their off study date. The Kaplan-Meier method was used to determine the median and 95% confidence interval. | Up to 15 months |
| Time to Distant Liver Failure | Time to distant liver failure was defined as the time from on study date to the date of distant liver failure. Patients who did not experience distant liver failure were censored at their date of last evaluation. The Kaplan-Meier method was used to determine the median and 95% confidence interval. | Up to 15 months |
| Time Until Salvage Treatment | Time until salvage treatment was defined as the time from on study date to the start date of salvage treatment. Patients who did not receive salvage treatment were censored at their off study date. The Kaplan-Meier method was used to determine the median and 95% confidence interval. | Up to 15 months |
| Number of Patients With Treatment-Related Adverse Events Grade 3 or Above | Number of unique patients who had a treatment-related (possible, probable, or definite) adverse event with grade 3 or greater using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. | Every 15 days for approximately 6 months |
| Change in MELD Score | Model for end-stage liver disease (MELD) score measures the severity of liver dysfunction. MELD scores range from 6 to 40 and are based on lab tests including serum creatinine, total bilirubin, and INR. The higher the number, the worse the liver function. | Up to 1 year |
The standard SBRT plan was chosen as the plan that reduced the dose of radiation to functional liver without compromising target coverage or tumor control. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Karnofsky Performance Status | The Karnofsky Performance Status (KPS) classifies patients based on their functional impairment. Lower KPS = worse survival KPS 100-Normal; no complaints; no evidence of disease KPS 90-Able to carry on normal activity; minor signs/symptoms of disease KPS 80-Normal activity with effort; some signs/symptoms of disease KPS 70-Cares for self; unable to carry on normal activity KPS 60-Requires occasional assistance KPS 50-Requires considerable assistance KPS 40-Disabled; requires special care KPS 30-Severely disabled KPS 20-Very sick; hospitalization necessary KPS 10-Moribund KPS 0-Dead | Count of Participants | Participants |
|
| Baseline MELD Score | Model for end-stage liver disease (MELD) score measures the severity of liver dysfunction. MELD scores range from 6 to 40 and are based on lab tests including serum creatinine, total bilirubin, and INR. The higher the number, the worse the liver function. | Mean | Standard Deviation | units on a scale |
|
The theragnostic SBRT plan using the HIDA scan was chosen as the plan that reduced the dose of radiation to functional liver without compromising target coverage or tumor control.
| OG001 | Standard SBRT Planning | The standard SBRT plan was chosen as the plan that reduced the dose of radiation to functional liver without compromising target coverage or tumor control. |
|
|
| Secondary | Percentage of Participants for Whom Theragnostically Planned Radiation is Chosen for the Radiation Treatment Plan | The percentage of participants for whom theragnostically planned radiation is chosen for the radiation treatment plan over the standard plan will be calculated along with the corresponding exact 95% Binomial confidence interval. | Patients who received at least one dose of radiation and completed both SBRT planning schemes. The two study arms are combined for this analysis because the arm was assigned based on the SBRT planning scheme that was ultimately chosen. | Posted | Number | 95% Confidence Interval | percentage of participants | Day -1 of Radiation Treatment |
|
|
|
| Secondary | Duration of Local Control | Duration of local control was assessed by calculating the time from on study date to date of local failure. Patients who did not experience local failure were censored at their last evaluation date. Local failure (progressive disease at primary diagnosis site) was evaluated using RECIST v1.1 criteria: Complete response: Disappearance of all target lesions; Partial response: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. The Kaplan-Meier method was used to determine the median and 95% confidence interval. | Patients who received at least one dose of radiation and completed both SBRT planning schemes. | Posted | Median | 95% Confidence Interval | months | Up to 15 months |
|
|
|
| Secondary | Progression Free Survival | Progression free survival was defined as the time from on study date to date of recurrence of any type or death from any cause. Patients who did not experience recurrence or death were censored at their last evaluation date. The Kaplan-Meier method was used to determine the median and 95% confidence interval. | Patients who received at least one dose of radiation and completed both SBRT planning schemes. | Posted | Median | 95% Confidence Interval | months | Up to 15 months |
|
|
|
| Secondary | Overall Survival | Overall survival was defined as the time from on study date to death due to any cause. Patients who remained alive were censored at their last known alive date. The Kaplan-Meier method was used to determine the median and 95% confidence interval. | Patients who received at least one dose of radiation and completed both SBRT planning schemes. | Posted | Median | 95% Confidence Interval | months | Up to 3 years |
|
|
|
| Secondary | Time to Transplant | Time to transplant was defined as the time from on study date to the date of transplant. Patients who did not receive transplant were censored at their off study date. The Kaplan-Meier method was used to determine the median and 95% confidence interval. | Patients who received at least one dose of radiation and completed both SBRT planning schemes. | Posted | Median | 95% Confidence Interval | months | Up to 15 months |
|
|
|
| Secondary | Time to Distant Liver Failure | Time to distant liver failure was defined as the time from on study date to the date of distant liver failure. Patients who did not experience distant liver failure were censored at their date of last evaluation. The Kaplan-Meier method was used to determine the median and 95% confidence interval. | Patients who received at least one dose of radiation and completed both SBRT planning schemes. | Posted | Median | 95% Confidence Interval | months | Up to 15 months |
|
|
|
| Secondary | Time Until Salvage Treatment | Time until salvage treatment was defined as the time from on study date to the start date of salvage treatment. Patients who did not receive salvage treatment were censored at their off study date. The Kaplan-Meier method was used to determine the median and 95% confidence interval. | Patients who received at least one dose of radiation and completed both SBRT planning schemes. | Posted | Median | 95% Confidence Interval | months | Up to 15 months |
|
|
|
| Secondary | Number of Patients With Treatment-Related Adverse Events Grade 3 or Above | Number of unique patients who had a treatment-related (possible, probable, or definite) adverse event with grade 3 or greater using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. | Patients who received at least one dose of radiation. | Posted | Count of Participants | Participants | Every 15 days for approximately 6 months |
|
|
|
| Secondary | Change in MELD Score | Model for end-stage liver disease (MELD) score measures the severity of liver dysfunction. MELD scores range from 6 to 40 and are based on lab tests including serum creatinine, total bilirubin, and INR. The higher the number, the worse the liver function. | Patients who received at least one dose of radiation and completed both SBRT planning schemes. Patient numbers differ due to missed visits and/or patients no longer being on study. | Posted | Mean | Standard Deviation | units on a scale | Up to 1 year |
|
|
|
| 4 |
| 9 |
| 3 |
| 9 |
| 9 |
| 9 |
| EG001 | Standard SBRT Planning | The standard SBRT plan was chosen as the plan that reduced the dose of radiation to functional liver without compromising target coverage or tumor control. | 2 | 5 | 1 | 5 | 4 | 5 |
| Small intestinal obstruction | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Sepsis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary 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 |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Chills | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| INR increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Sleep apnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
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| D008107 |
| Liver Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| Change from Baseline to Mid-Treatment |
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| Change from Baseline to 1 Month |
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| Change from Baseline to 3 Month |
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| Change from Baseline to 6 Month |
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| Change from Baseline 12 Month |
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