Trial Outcomes & Findings for A Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer (NCT NCT01522937)
NCT ID: NCT01522937
Last Updated: 2017-03-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
94 participants
Primary outcome timeframe
1 Year
Results posted on
2017-03-09
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
146
|
|
Overall Study
COMPLETED
|
146
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer
Baseline characteristics by cohort
| Measure |
Liver Cancer Patients
n=146 Participants
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.
|
|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Gender
Female
|
30 Participants
n=5 Participants
|
|
Gender
Male
|
116 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 YearFor 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.
Outcome measures
| Measure |
Liver Cancer Patients
n=102 Participants
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.
|
|---|---|
|
The Percentage of Patients With Local Control at 1 Year Post Treatment
|
99 percentage of patients
Interval 97.0 to 100.0
|
SECONDARY outcome
Timeframe: 1 YearProgression is defined as a greater than or equal to 20% growth of a lesion from the smallest lesion measurement
Outcome measures
| Measure |
Liver Cancer Patients
n=102 Participants
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.
|
|---|---|
|
The Percentage of Patients Alive Without Progression at 1 Year
|
62 percentage of patients
Interval 53.0 to 71.0
|
SECONDARY outcome
Timeframe: 1 YearOutcome measures
| Measure |
Liver Cancer Patients
n=102 Participants
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.
|
|---|---|
|
The Percentage of Patients Alive at 1 Year
|
67 percentage of patients
Interval 58.0 to 78.0
|
SECONDARY outcome
Timeframe: 1 YearGrade 4 toxicities are life threatening toxicities that require urgent attention.
Outcome measures
| Measure |
Liver Cancer Patients
n=102 Participants
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.
|
|---|---|
|
The Number of Patients Who Experience Grade 4+ Hepatotoxicity
|
0 patients
|
SECONDARY outcome
Timeframe: 1 YearGrade 4 toxicities are life threatening toxicities that require urgent attention.
Outcome measures
| Measure |
Liver Cancer Patients
n=102 Participants
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.
|
|---|---|
|
The Number of Patients That Experience Grade 4+ Gastrointestinal Bleeding
|
0 patients
|
Adverse Events
Liver Cancer Patients
Serious events: 22 serious events
Other events: 81 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Liver Cancer Patients
n=146 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.68%
1/146 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.68%
1/146 • Number of events 1
|
|
Cardiac disorders
Chest pain - cardiac
|
0.68%
1/146 • Number of events 1
|
|
Cardiac disorders
Heart failure
|
0.68%
1/146 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.68%
1/146 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
0.68%
1/146 • Number of events 1
|
|
Gastrointestinal disorders
Esophageal varices hemorrhage
|
0.68%
1/146 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
0.68%
1/146 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.68%
1/146 • Number of events 1
|
|
General disorders
Chills
|
0.68%
1/146 • Number of events 1
|
|
General disorders
Multi-organ failure
|
0.68%
1/146 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.68%
1/146 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.68%
1/146 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.68%
1/146 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.68%
1/146 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
0.68%
1/146 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.68%
1/146 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.68%
1/146 • Number of events 1
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
0.68%
1/146 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.68%
1/146 • Number of events 1
|
|
Nervous system disorders
Encephalopathy
|
0.68%
1/146 • Number of events 1
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
0.68%
1/146 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
0.68%
1/146 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.68%
1/146 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.68%
1/146 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
0.68%
1/146 • Number of events 2
|
|
Social circumstances
Social circumstances - Other
|
0.68%
1/146 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.68%
1/146 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
2/146 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
1.4%
2/146 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
1.4%
2/146 • Number of events 2
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
1.4%
2/146 • Number of events 3
|
|
General disorders
Fatigue
|
1.4%
2/146 • Number of events 2
|
|
General disorders
Fever
|
1.4%
2/146 • Number of events 2
|
|
Infections and infestations
Lung infection
|
1.4%
2/146 • Number of events 2
|
|
Psychiatric disorders
Psychiatric disorders - Other
|
1.4%
2/146 • Number of events 2
|
|
Renal and urinary disorders
Acute kidney injury
|
1.4%
2/146 • Number of events 2
|
|
Vascular disorders
Thromboembolic event
|
1.4%
2/146 • Number of events 2
|
|
Gastrointestinal disorders
Ascites
|
2.1%
3/146 • Number of events 3
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other
|
2.1%
3/146 • Number of events 3
|
Other adverse events
| Measure |
Liver Cancer Patients
n=146 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Sick sinus syndrome
|
0.68%
1/146 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
1.4%
2/146 • Number of events 2
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other
|
0.68%
1/146 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
0.68%
1/146 • Number of events 1
|
|
Eye disorders
Blurred vision
|
0.68%
1/146 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
2.1%
3/146 • Number of events 3
|
|
Gastrointestinal disorders
Bloating
|
0.68%
1/146 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
2.7%
4/146 • Number of events 4
|
|
Gastrointestinal disorders
Esophagitis
|
0.68%
1/146 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
14.4%
21/146 • Number of events 22
|
|
Gastrointestinal disorders
Oral pain
|
0.68%
1/146 • Number of events 1
|
|
General disorders
Edema limbs
|
3.4%
5/146 • Number of events 6
|
|
General disorders
General disorders and administration site conditions - Other
|
3.4%
5/146 • Number of events 5
|
|
General disorders
Non-cardiac chest pain
|
0.68%
1/146 • Number of events 1
|
|
General disorders
Pain
|
2.1%
3/146 • Number of events 3
|
|
Hepatobiliary disorders
Hepatic failure
|
0.68%
1/146 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic pain
|
22.6%
33/146 • Number of events 38
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.68%
1/146 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
1.4%
2/146 • Number of events 2
|
|
Investigations
Alkaline phosphatase increased
|
1.4%
2/146 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
1.4%
2/146 • Number of events 2
|
|
Investigations
CD4 lymphocytes decreased
|
0.68%
1/146 • Number of events 1
|
|
Investigations
Creatinine increased
|
0.68%
1/146 • Number of events 1
|
|
Investigations
INR increased
|
0.68%
1/146 • Number of events 1
|
|
Investigations
Lipase increased
|
0.68%
1/146 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
14.4%
21/146 • Number of events 24
|
|
Investigations
Neutrophil count decreased
|
1.4%
2/146 • Number of events 2
|
|
Investigations
Platelet count decreased
|
8.2%
12/146 • Number of events 18
|
|
Investigations
Serum amylase increased
|
0.68%
1/146 • Number of events 1
|
|
Investigations
White blood cell decreased
|
4.8%
7/146 • Number of events 12
|
|
Metabolism and nutrition disorders
Acidosis
|
0.68%
1/146 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
2.1%
3/146 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.4%
2/146 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.7%
4/146 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.68%
1/146 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.68%
1/146 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.1%
3/146 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
0.68%
1/146 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.68%
1/146 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.68%
1/146 • Number of events 1
|
|
Nervous system disorders
Ataxia
|
0.68%
1/146 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
0.68%
1/146 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
1.4%
2/146 • Number of events 2
|
|
Nervous system disorders
Dysarthria
|
0.68%
1/146 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
0.68%
1/146 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.68%
1/146 • Number of events 2
|
|
Nervous system disorders
Seizure
|
0.68%
1/146 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.68%
1/146 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
1.4%
2/146 • Number of events 2
|
|
Psychiatric disorders
Confusion
|
2.1%
3/146 • Number of events 4
|
|
Psychiatric disorders
Depression
|
2.1%
3/146 • Number of events 3
|
|
Psychiatric disorders
Personality change
|
0.68%
1/146 • Number of events 1
|
|
Renal and urinary disorders
Hematuria
|
0.68%
1/146 • Number of events 1
|
|
Renal and urinary disorders
Urine discoloration
|
1.4%
2/146 • Number of events 2
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.4%
2/146 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.4%
5/146 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.7%
4/146 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.68%
1/146 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.68%
1/146 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.68%
1/146 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.68%
1/146 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
2.7%
4/146 • Number of events 4
|
|
Vascular disorders
Hypertension
|
1.4%
2/146 • Number of events 2
|
|
Blood and lymphatic system disorders
Anemia
|
6.2%
9/146 • Number of events 10
|
|
Gastrointestinal disorders
Diarrhea
|
1.4%
2/146 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
5.5%
8/146 • Number of events 11
|
|
General disorders
Chills
|
0.68%
1/146 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
0.68%
1/146 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
4.1%
6/146 • Number of events 10
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
2/146 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.1%
6/146 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.68%
1/146 • Number of events 1
|
|
Nervous system disorders
Encephalopathy
|
1.4%
2/146 • Number of events 3
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
0.68%
1/146 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.68%
1/146 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
2.1%
3/146 • Number of events 5
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
1.4%
2/146 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
4.8%
7/146 • Number of events 8
|
|
General disorders
Fatigue
|
43.8%
64/146 • Number of events 94
|
|
General disorders
Fever
|
0.68%
1/146 • Number of events 2
|
|
Psychiatric disorders
Psychiatric disorders - Other
|
1.4%
2/146 • Number of events 2
|
|
Renal and urinary disorders
Acute kidney injury
|
0.68%
1/146 • Number of events 1
|
|
Vascular disorders
Thromboembolic event
|
0.68%
1/146 • Number of events 1
|
|
Gastrointestinal disorders
Ascites
|
6.2%
9/146 • Number of events 10
|
Additional Information
Dr. Kyle Cuneo, M.D.
University of Michigan Comprehensive Cancer Center
Phone: 734-936-4300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place