ENCORE-VT: Phase I/II Study of EP-guided Noninvasive Cardiac Radioablation for Treatment of Ventricular Tachycardia

Sponsor
Washington University School of Medicine (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02919618
Collaborator
(none)
19
Enrollment
1
Location
1
Arm
90
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Phase I/II Study of EP-guided Noninvasive Cardiac Radioablation (ENCORE) for Treatment of Ventricular Tachycardia

Condition or DiseaseIntervention/TreatmentPhase
  • Radiation: stereotactic body radiotherapy (SBRT)
Phase 1/Phase 2

Detailed Description

Patients with Ventricular Tachycardia (VT) who have failed standard therapy (medicines, invasive catheter ablation) have limited options, with one-year survival below 20%. Preclinical data demonstrate that single fraction stereotactic body radiotherapy (SBRT) to discrete portions of the heart is feasible and may result in a reduction or elimination of VT. The efficacy may be further improved when guided by cardiac electrophysiologic (EP) testing. In total, the mapping and ablation proposed for this EP-guided Noninvasive Cardiac Radioablation (ENCORE) is a rapid and totally non-invasive method. Overall safety and early efficacy of ENCORE have not been rigorously studied in a prospective trial to-date. The purpose of this phase I/II study is to demonstrate the short-term safety and preliminary efficacy of ENCORE for patients with life-threatening, treatment-refractory VT.

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I/II Study of EP-guided Noninvasive Cardiac Radioablation for Treatment of Ventricular Tachycardia
Actual Study Start Date :
Jul 1, 2016
Actual Primary Completion Date :
Jul 23, 2018
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

ArmIntervention/Treatment
Experimental: stereotactic body radiotherapy (SBRT)

Noninvasive SBRT will be delivered in a single fraction to a region of the heart determined by EP-guidance, using noninvasive electrical mapping combined with anatomic imaging.

Radiation: stereotactic body radiotherapy (SBRT)
(Cardiac ablative radiotherapy)

Outcome Measures

Primary Outcome Measures

  1. Number of Serious Adverse Events [< or = 90 days]

    Demonstrate acute (≤ 90 days) safety of noninvasive stereotactic cardiac ablation radiotherapy (ENCORE). The primary safety endpoint is defined by a ≤ 20% rate of serious adverse events (SAEs) using CTCAE v4.0 criteria that are possibly/probably/definitely related to study treatment, based on previously published data for expected invasive catheter-based VT-ablation procedures.

  2. Number of Participants With Reduction in Ventricular Tachycardia (VT) Burden [12 months (6mo prior to and 6mo post SBRT)]

    Primary efficacy endpoint is defined by the number of subjects with a reduction in VT burden comparing the period six months before ENCORE treatment to the six months after ENCORE treatment as adjudicated by continuous ICD monitoring (number of ATP and ICD shocks and sustained (>30 second) nontreated slow VT). There will be a six-week "blanking period" after therapy to allow for ablation effect. For patients with PVC-induced cardiomyopathy, the primary efficacy will be any reduction in PVC burden based on ambulatory heart monitors.

Secondary Outcome Measures

  1. Overall Survival [12 months]

    Determine six-month and twelve-month survival (overall mortality endpoint) after treatment with ENCORE.

  2. Number of Adverse Events That Are Possibly/Probably/Definitely Related to Study Treatment [90 days to 12 months]

    Toxicities that occur after treatment, but are not acutely ascribed to treatment that are possibly/probably/definitely related to study treatment, based on previously published data for expected invasive catheter-based VT-ablation procedures, using the CTCAE v4.0 criteria.

  3. Health Related Quality of Life (HRQOL) [6 week, 6 month, 12 month]

    The 36-Item Short Form Survey (SF-36) is a set of generic, coherent, and easily administered quality of life measures that rely on patient self-reporting. The SF-36 evaluates 8 domains: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Scale values for each domain range from 0 to 100 where the higher score defines a more favorable health state.

  4. Number of Participants With a 50% Reduction in Ventricular Tachycardia (VT) Burden [6 months]

    Evaluate stricter efficacy endpoint of ENCORE treatment, as defined by number of patients who have had 50% reduction in any VT therapies (ATP or ICD shocks or sustained (>30sec) nontreated slow VT) after ENCORE treatment (6 months before vs. 6 months after treatment, with a 6 week blanking period immediately after treatment). For patients with PVC-induced cardiomyopathy, the stricter efficacy will be >50% reduction in PVC burden based on ambulatory heart monitors.

  5. Number of Participants With a 95% Reduction in Ventricular Tachycardia (VT) Burden [6 months]

    Evaluate strictest efficacy endpoint of ENCORE treatment, as defined by number of patients who have had 95% reduction in any VT (ATP or ICD shocks or sustained (>30 sec) slow VT) after ENCORE treatment (6 months before vs. 6 months after treatment, with a 6 week blanking period immediately after treatment). For patients with PVC-induced cardiomyopathy, the strictest efficacy will be abolition of PVC burden (<1%) based on ambulatory heart monitors.

  6. Number of Participants With Reduction in ICD Shocks and LVEF Improvement [6 months]

    Evaluate the most clinically useful efficacy endpoint of ENCORE treatment, namely, number of patients with reduction specifically in ICD shocks (6 months before vs. 6 months after treatment, with a 6 week blanking period immediately after treatment). For patients with PVC-induced cardiomyopathy, the most clinically useful efficacy will be improvement in cardiac function in the setting of any improvement in PVC burden.

  7. Number of Participants With Reduction in Ventricular Tachycardia (VT) Therapies Between 6 and 12 Months [12 months]

    Evaluate longer-term durability endpoint of ENCORE treatment, as defined by number of patients with reduction in VT therapies (ATP or ICD shock or sustained (>30 sec) slow VT and ICD shock alone) during the early phase (treatment to 6 months, with 6 week blanking period) vs. the late phase (6 months to 1 year). For patients with PVC-induced cardiomyopathy, the longer-term durability efficacy will be persistence of any reduction in PVC burden based on ambulatory heart monitors during early phase vs. late phase.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. DOCUMENTED VT:

  2. Patient must have documented sustained monomorphic ventricular tachycardia as documented on either a 12-lead ECG or intracardiac ICD interrogation

  • OR-
  1. Monomorphic PVCs documented on a 12-lead ECG.

  2. ANTIARRHYTHMIC MEDICATION: Patient must have failed or become intolerant to at least one antiarrhythmic medication (amiodarone, sotalol, or mexiletine).

-AND-

  1. CATHETER ABLATION: Patient must have failed at least one invasive catheter ablation procedure, or have a contraindication to a catheter ablation procedure (e.g., LV thrombus, severe pulmonary disease), or have VT thought to arise from a protected location (e.g., epicardial VT with history of previous cardiac surgery).

  2. MINIMUM VT BURDEN: Patient must have either:

  3. At least 3 VT episodes (sustained VT, ICD ATP or ICD shock) over previous 6 months prior to enrollment -OR-

  4. 20% PVC burden with a cardiomyopathy (LVEF<50%)

  5. Patient must be deemed medically fit for stereotactic body radiation therapy by the treating physician.

  6. Patient must be > 18 years old.

  7. Patient must be able to understand and be willing to sign an IRB approved written informed consent document.

Exclusion Criteria:
  1. Patient must not have past history of radiotherapy within the projected treatment field.

  2. Advanced symptomatic heart failure as defined as NYHA Class IV heart failure (inotrope dependent and/or current left-ventricular assist device (LVAD))

  3. Polymorphic VT or ventricular fibrillation (VF) as a clinical heart rhythm (as determined by 12-lead ECG and/or ICD interrogation).

  4. More than 3 distinct clinical VT morphologies observed (ECG or ICD interrogation or invasive EP study) OR more than 5 distinct induced VT morphologies during ECGI testing.

  5. Advanced myocardial scar substrate that would require stereotactic delivery to a target volume deemed unsafe by the treating physician.

  6. Unlikely to live 12 months, in the absence of VT, as best based on clinical judgment by the treating and enrolling physicians.

  7. Patient must not be pregnant and/or breastfeeding and must have a negative pregnancy test within 14 days of study entry.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Washington University School of MedicineSaint LouisMissouriUnited States63110

Sponsors and Collaborators

  • Washington University School of Medicine

Investigators

  • Principal Investigator: Phillip Cuculich, MD, Washington University School of Medicine

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Phillip Cuculich, M.D., Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT02919618
Other Study ID Numbers:
  • 201606081
First Posted:
Sep 29, 2016
Last Update Posted:
Dec 2, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Phillip Cuculich, M.D., Washington University School of Medicine
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment DetailsTwenty-one patients were consented between July 11, 2016 and December 20, 2017. These patients were evaluated as either inpatient or outpatient. Once patients met initial enrollment criteria, screening procedures were conducted to determine if the patient was eligible for SBRT.
Pre-assignment DetailNineteen patients were consented, screened, and deemed eligible for SBRT. Two additional patients signed consent and went through screening procedures; however, were later deemed ineligible to obtain SBRT.
Arm/Group TitlePatients Overall Who Received SBRT
Arm/Group DescriptionNoninvasive Stereotactic Body Radiotherapy (SBRT) will be delivered in a single fraction to a region of the heart determined by EP-guidance, using noninvasive electrical mapping combined with anatomic imaging. Stereotactic Body Radiotherapy (SBRT): (Cardiac ablative radiotherapy)
Period Title: Overall Study
STARTED19
Primary Safety Endpoint (</=90 Days)19
Primary Efficacy Endpoint (6 Months)18
COMPLETED18
NOT COMPLETED1

Baseline Characteristics

Arm/Group TitlePatients Overall Who Received SBRT
Arm/Group DescriptionNoninvasive SBRT will be delivered in a single fraction to a region of the heart determined by EP-guidance, using noninvasive electrical mapping combined with anatomic imaging. Stereotactic Body Radiotherapy (SBRT): (Cardiac ablative radiotherapy)
Overall Participants19
Age (years) [Median (Full Range) ]
Median (Full Range) [years]
66
Sex: Female, Male (Count of Participants)
Female
2
10.5%
Male
17
89.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
Asian
1
5.3%
Native Hawaiian or Other Pacific Islander
0
0%
Black or African American
1
5.3%
White
17
89.5%
More than one race
0
0%
Unknown or Not Reported
0
0%
BMI (kg/m^2) [Median (Full Range) ]
Median (Full Range) [kg/m^2]
33.0
Age-Adjusted Charlson Comorbidity Index (Score) [Median (Full Range) ]
Median (Full Range) [Score]
4
Type of Cardiomyopathy (Count of Participants)
Ischemic Cardiomyopathy
11
57.9%
Nonischemic Cardiomyopathy
8
42.1%
Type of Nonischemic Cardiomyopathy (Count of Participants)
Idiopathic
5
26.3%
Myocarditis (Chronic)
2
10.5%
Valvular
1
5.3%
New York Heart Association (NYHA) Class (Count of Participants)
NYHA I
1
5.3%
NYHA II
4
21.1%
NYHA III
10
52.6%
NYHA IV
4
21.1%
Left Ventricular Ejection Fraction (Percentage of Ejection Fraction) [Median (Full Range) ]
Median (Full Range) [Percentage of Ejection Fraction]
25
Number of Previous Catheter Ablations (Invasive Procedures) [Median (Full Range) ]
Median (Full Range) [Invasive Procedures]
1
Total Number of Prior Catheter Ablation Approaches (Invasive Ablation Approaches) [Number]
Endocardial
25
Epicardial
4
Study Eligibility Criteria (Count of Participants)
Incessant Ventricular Tachycardia (VT)
2
10.5%
VT Storm (>3 episodes of VT in 24 hours)
10
52.6%
ICD Therapies (>3 shocks or ATP in 6 months)
5
26.3%
PVC-Related Cardiomyopathy
2
10.5%
Device (Count of Participants)
Single- or Dual-Chamber ICD
8
42.1%
Biventricular ICD
10
52.6%
No Device
1
5.3%
Current Antiarrhythmic Drugs (Count of Participants) [Number]
>1 Antiarrhythmic Drug at Baseline
11
57.9%
High-Dose Amiodarone (>/=300mg per day)
10
52.6%
Low-Dose Amiodarone (<300mg per day)
2
10.5%
Class III (excluding amiodarone)
7
36.8%
Class I
11
57.9%
Other Medications (Count of Participants) [Number]
Beta Blocker
18
94.7%
Angiotensin Converting Enzyme Inhibitor
10
52.6%
Angiotensin Receptor Blocker
7
36.8%
Oral Anticoagulation
14
73.7%
Variable (Count of Participants) [Number]
Chronic Obstructive Pulmonary Disease/Emphysema
4
21.1%
Diabetes Mellitus, Type II
7
36.8%
Hypertension
10
52.6%
Chronic Kidney Disease (Stage >/=3)
9
47.4%

Outcome Measures

1. Primary Outcome
TitleNumber of Serious Adverse Events
DescriptionDemonstrate acute (≤ 90 days) safety of noninvasive stereotactic cardiac ablation radiotherapy (ENCORE). The primary safety endpoint is defined by a ≤ 20% rate of serious adverse events (SAEs) using CTCAE v4.0 criteria that are possibly/probably/definitely related to study treatment, based on previously published data for expected invasive catheter-based VT-ablation procedures.
Time Frame< or = 90 days

Outcome Measure Data

Analysis Population Description
Analysis is based on number of SAE events that occurred in 19 participants within 90 days after SBRT.
Arm/Group TitleNumber of Events
Arm/Group DescriptionNumber of serious adverse events that occurred.
Measure Participants19
Grade 3 treatment-related SAE
2
Grade 4 treatment-related SAE
0
Grade 5 treatment-related SAE
0
Grade 5 SAE (not treatment-related)
1
2. Primary Outcome
TitleNumber of Participants With Reduction in Ventricular Tachycardia (VT) Burden
DescriptionPrimary efficacy endpoint is defined by the number of subjects with a reduction in VT burden comparing the period six months before ENCORE treatment to the six months after ENCORE treatment as adjudicated by continuous ICD monitoring (number of ATP and ICD shocks and sustained (>30 second) nontreated slow VT). There will be a six-week "blanking period" after therapy to allow for ablation effect. For patients with PVC-induced cardiomyopathy, the primary efficacy will be any reduction in PVC burden based on ambulatory heart monitors.
Time Frame12 months (6mo prior to and 6mo post SBRT)

Outcome Measure Data

Analysis Population Description
Percent reduction of VT episodes or PVC burden 6 months post-SBRT compared to 6 months prior to SBRT. Patients who were alive at 6 months were evaluated comparing ICD treatments or PVC burden 6 months before and 6 months post-SBRT.
Arm/Group TitlePatients With ICD-treated VT IndicationPatients With PVC-Related Cardiomyopathy Indication
Arm/Group DescriptionSixteen evaluable patients out of the overall 18 patients alive at 6 months who were enrolled with an ICD-treated VT indication.Two evaluable patients out of the overall 18 patients alive at 6 months who were enrolled with a PVC indication.
Measure Participants162
Count of Participants [Participants]
15
78.9%
2
NaN
3. Secondary Outcome
TitleOverall Survival
DescriptionDetermine six-month and twelve-month survival (overall mortality endpoint) after treatment with ENCORE.
Time Frame12 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title6 Month Overall Survival12 Month Overall Survival
Arm/Group DescriptionOverall survival at the 6 month post-SBRT time point of all 19 patients enrolled.Overall survival at the 12 month post-SBRT time point of the 18 remaining patients from the 6 month time point.
Measure Participants1918
Count of Participants [Participants]
18
94.7%
13
NaN
4. Secondary Outcome
TitleNumber of Adverse Events That Are Possibly/Probably/Definitely Related to Study Treatment
DescriptionToxicities that occur after treatment, but are not acutely ascribed to treatment that are possibly/probably/definitely related to study treatment, based on previously published data for expected invasive catheter-based VT-ablation procedures, using the CTCAE v4.0 criteria.
Time Frame90 days to 12 months

Outcome Measure Data

Analysis Population Description
Analysis is based on number of AE events that occurred in 18 participants >90 days to 365 days post-SBRT.
Arm/Group TitleNumber of Events
Arm/Group DescriptionNumber of adverse events that occurred.
Measure Participants19
Grade 1 Possibly Related AE
15
Grade 1 Probably Related AE
1
Grade 2 Possibly Related AE
9
Grade 2 Probably Related AE
1
Grade 2 Definitely Related AE
1
Grade 3 Possibly Related AE
20
Grade 4 Possibly Related AE
1
Grade 5 Possibly Related AE
1
5. Secondary Outcome
TitleHealth Related Quality of Life (HRQOL)
DescriptionThe 36-Item Short Form Survey (SF-36) is a set of generic, coherent, and easily administered quality of life measures that rely on patient self-reporting. The SF-36 evaluates 8 domains: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Scale values for each domain range from 0 to 100 where the higher score defines a more favorable health state.
Time Frame6 week, 6 month, 12 month

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleBaseline6 Week6 Month12 Month
Arm/Group DescriptionBaseline mean scores for all 18 evaluable patients at the 6 week time point.6 week mean scores for all 18 evaluable patients at the 6 week time point.6 month mean scores for all 16 evaluable patients at the 6 month time point. 2 patients did not return the SF-36 survey for the 6 month follow up.12 month mean scores for all 13 evaluable patients at the 12 month time point. 5 patients had expired prior to the 12 month time point.
Measure Participants18181613
Social Functioning
64
70
87
72
General Health
44
52
49
54
Health Change
28
61
77
65
6. Secondary Outcome
TitleNumber of Participants With a 50% Reduction in Ventricular Tachycardia (VT) Burden
DescriptionEvaluate stricter efficacy endpoint of ENCORE treatment, as defined by number of patients who have had 50% reduction in any VT therapies (ATP or ICD shocks or sustained (>30sec) nontreated slow VT) after ENCORE treatment (6 months before vs. 6 months after treatment, with a 6 week blanking period immediately after treatment). For patients with PVC-induced cardiomyopathy, the stricter efficacy will be >50% reduction in PVC burden based on ambulatory heart monitors.
Time Frame6 months

Outcome Measure Data

Analysis Population Description
One patient was excluded because they expired prior to the outcome measure time frame.
Arm/Group TitlePatients Overall Who Received SBRT
Arm/Group DescriptionNoninvasive Stereotactic Body Radiotherapy (SBRT) will be delivered in a single fraction to a region of the heart determined by EP-guidance, using noninvasive electrical mapping combined with anatomic imaging. Stereotactic Body Radiotherapy (SBRT): (Cardiac ablative radiotherapy)
Measure Participants18
Count of Participants [Participants]
17
89.5%
7. Secondary Outcome
TitleNumber of Participants With a 95% Reduction in Ventricular Tachycardia (VT) Burden
DescriptionEvaluate strictest efficacy endpoint of ENCORE treatment, as defined by number of patients who have had 95% reduction in any VT (ATP or ICD shocks or sustained (>30 sec) slow VT) after ENCORE treatment (6 months before vs. 6 months after treatment, with a 6 week blanking period immediately after treatment). For patients with PVC-induced cardiomyopathy, the strictest efficacy will be abolition of PVC burden (<1%) based on ambulatory heart monitors.
Time Frame6 months

Outcome Measure Data

Analysis Population Description
One patient was excluded because they expired prior to the outcome measure time frame.
Arm/Group TitlePatients Overall Who Received SBRT
Arm/Group DescriptionNoninvasive Stereotactic Body Radiotherapy (SBRT) will be delivered in a single fraction to a region of the heart determined by EP-guidance, using noninvasive electrical mapping combined with anatomic imaging. Stereotactic Body Radiotherapy (SBRT): (Cardiac ablative radiotherapy)
Measure Participants18
Count of Participants [Participants]
11
57.9%
8. Secondary Outcome
TitleNumber of Participants With Reduction in ICD Shocks and LVEF Improvement
DescriptionEvaluate the most clinically useful efficacy endpoint of ENCORE treatment, namely, number of patients with reduction specifically in ICD shocks (6 months before vs. 6 months after treatment, with a 6 week blanking period immediately after treatment). For patients with PVC-induced cardiomyopathy, the most clinically useful efficacy will be improvement in cardiac function in the setting of any improvement in PVC burden.
Time Frame6 months

Outcome Measure Data

Analysis Population Description
One patient was excluded because they expired prior to the outcome measure time frame.
Arm/Group TitlePatients Overall Who Received SBRT
Arm/Group DescriptionNoninvasive Stereotactic Body Radiotherapy (SBRT) will be delivered in a single fraction to a region of the heart determined by EP-guidance, using noninvasive electrical mapping combined with anatomic imaging. Stereotactic Body Radiotherapy (SBRT): (Cardiac ablative radiotherapy)
Measure Participants18
Count of Participants [Participants]
13
68.4%
9. Secondary Outcome
TitleNumber of Participants With Reduction in Ventricular Tachycardia (VT) Therapies Between 6 and 12 Months
DescriptionEvaluate longer-term durability endpoint of ENCORE treatment, as defined by number of patients with reduction in VT therapies (ATP or ICD shock or sustained (>30 sec) slow VT and ICD shock alone) during the early phase (treatment to 6 months, with 6 week blanking period) vs. the late phase (6 months to 1 year). For patients with PVC-induced cardiomyopathy, the longer-term durability efficacy will be persistence of any reduction in PVC burden based on ambulatory heart monitors during early phase vs. late phase.
Time Frame12 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePatients Overall Who Received SBRT
Arm/Group DescriptionNoninvasive SBRT will be delivered in a single fraction to a region of the heart determined by EP-guidance, using noninvasive electrical mapping combined with anatomic imaging. Stereotactic Body Radiotherapy (SBRT): (Cardiac ablative radiotherapy)
Measure Participants18
Count of Participants [Participants]
16
84.2%

Adverse Events

Time FrameAdverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Adverse Event Reporting Description
Arm/Group TitlePatients Overall Who Received SBRT
Arm/Group DescriptionNoninvasive Stereotactic Body Radiotherapy (SBRT) will be delivered in a single fraction to a region of the heart determined by EP-guidance, using noninvasive electrical mapping combined with anatomic imaging. Stereotactic Body Radiotherapy (SBRT): (Cardiac ablative radiotherapy)
All Cause Mortality
Patients Overall Who Received SBRT
Affected / at Risk (%)# Events
Total8/19 (42.1%)
Serious Adverse Events
Patients Overall Who Received SBRT
Affected / at Risk (%)# Events
Total15/19 (78.9%)
Blood and lymphatic system disorders
Anemia1/19 (5.3%)
Cardiac disorders
Atrial Fibrillation1/19 (5.3%)
Cardiac Arrest3/19 (15.8%)
Heart Failure6/19 (31.6%)
Other - Chest Pain NOS2/19 (10.5%)
Other - ICD Lead Fracture1/19 (5.3%)
Palpitations1/19 (5.3%)
Pericardial Effusion2/19 (10.5%)
Pericarditis1/19 (5.3%)
Ventricular Fibrillation1/19 (5.3%)
Ventricular Tachycardia9/19 (47.4%)
Gastrointestinal disorders
Diarrhea1/19 (5.3%)
Gastric Hemorrhage1/19 (5.3%)
Retroperitoneal Hemorrhage1/19 (5.3%)
General disorders
Multi-organ Failure1/19 (5.3%)
Other - Accident1/19 (5.3%)
Hepatobiliary disorders
Cholecystitis1/19 (5.3%)
Hepatic Failure1/19 (5.3%)
Infections and infestations
Urinary Tract Infection1/19 (5.3%)
Injury, poisoning and procedural complications
Intraoperative Cardiac Injury1/19 (5.3%)
Metabolism and nutrition disorders
Acidosis1/19 (5.3%)
Dehydration1/19 (5.3%)
Nervous system disorders
Cognitive Disturbance1/19 (5.3%)
Renal and urinary disorders
Acute Kidney Injury2/19 (10.5%)
Respiratory, thoracic and mediastinal disorders
Dyspnea2/19 (10.5%)
Hypoxia2/19 (10.5%)
Other - Chemical Pneumonitis1/19 (5.3%)
Other - Pneumonia2/19 (10.5%)
Pneumothorax1/19 (5.3%)
Respiratory Failure2/19 (10.5%)
Vascular disorders
Flushing1/19 (5.3%)
Hematoma1/19 (5.3%)
Hypertension1/19 (5.3%)
Hypotension3/19 (15.8%)
Other (Not Including Serious) Adverse Events
Patients Overall Who Received SBRT
Affected / at Risk (%)# Events
Total19/19 (100%)
Cardiac disorders
Acute Coronary Syndrome1/19 (5.3%)
Atrial Fibrillation2/19 (10.5%)
Heart Failure8/19 (42.1%)
Mitral Valve Disease1/19 (5.3%)
Other - Chest Pain NOS8/19 (42.1%)
Palpitations1/19 (5.3%)
Pericardial Effusion5/19 (26.3%)
Pericarditis1/19 (5.3%)
Sinus Tachycardia1/19 (5.3%)
Ventricular Fibrillation1/19 (5.3%)
Ear and labyrinth disorders
Ear Pain1/19 (5.3%)
Gastrointestinal disorders
Abdominal Pain2/19 (10.5%)
Colitis1/19 (5.3%)
Constipation1/19 (5.3%)
Dyspepsia6/19 (31.6%)
Nausea6/19 (31.6%)
Other - Congestive Gastropathy1/19 (5.3%)
Other - Dark Stools1/19 (5.3%)
Other - Gastroenteritis1/19 (5.3%)
Other - Polydipsia1/19 (5.3%)
Retroperitoneal Hemorrhage1/19 (5.3%)
Stomach Pain1/19 (5.3%)
Vomiting5/19 (26.3%)
General disorders
Chills1/19 (5.3%)
Fatigue12/19 (63.2%)
Malaise1/19 (5.3%)
Hepatobiliary disorders
Cholecystitis1/19 (5.3%)
Immune system disorders
Allergic Reaction1/19 (5.3%)
Infections and infestations
Sepsis1/19 (5.3%)
Sinusitis1/19 (5.3%)
Upper Respiratory Infection3/19 (15.8%)
Urinary Tract Infection1/19 (5.3%)
Injury, poisoning and procedural complications
Ankle Fracture1/19 (5.3%)
Fracture1/19 (5.3%)
Investigations
Alanine Aminotransferase Increased1/19 (5.3%)
Alkaline Phosphatase Increased1/19 (5.3%)
Aspartate Aminotransferase Increased1/19 (5.3%)
Blood Bilirubin Increased1/19 (5.3%)
Metabolism and nutrition disorders
Hyperglycemia1/19 (5.3%)
Musculoskeletal and connective tissue disorders
Arthritis1/19 (5.3%)
Back Pain4/19 (21.1%)
Chest Wall Pain1/19 (5.3%)
Other - Shoulder Pain1/19 (5.3%)
Other - Tendon Rupture1/19 (5.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cyst1/19 (5.3%)
Nervous system disorders
Dizziness9/19 (47.4%)
Dysesthesia3/19 (15.8%)
Headache2/19 (10.5%)
Hypersomnia1/19 (5.3%)
Paresthesia1/19 (5.3%)
Presyncope1/19 (5.3%)
Seizure1/19 (5.3%)
Spacticity1/19 (5.3%)
Syncope1/19 (5.3%)
Tremors1/19 (5.3%)
Psychiatric disorders
Agitation1/19 (5.3%)
Renal and urinary disorders
Acute Kidney Injury1/19 (5.3%)
Hematuria2/19 (10.5%)
Other - Dysuria1/19 (5.3%)
Other - Nephrolithiasis1/19 (5.3%)
Reproductive system and breast disorders
Testicular Pain1/19 (5.3%)
Respiratory, thoracic and mediastinal disorders
Cough3/19 (15.8%)
Dyspnea8/19 (42.1%)
Hypoxia1/19 (5.3%)
Other - Influenza1/19 (5.3%)
Other - Pneumonia2/19 (10.5%)
Other - Radiation Pneumonitis2/19 (10.5%)
Pleural Effusion2/19 (10.5%)
Pleuritic Pain1/19 (5.3%)
Pulmonary Edema1/19 (5.3%)
Wheezing1/19 (5.3%)
Skin and subcutaneous tissue disorders
Hyperhidrosis2/19 (10.5%)
Vascular disorders
Hematoma1/19 (5.3%)
Hypertension1/19 (5.3%)
Hypotension8/19 (42.1%)
Thromboembolic Event1/19 (5.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleDr. Phillip Cuculich
OrganizationWashington University
Phone314-454-7698
Emailpcuculic@wustl.edu
Responsible Party:
Phillip Cuculich, M.D., Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT02919618
Other Study ID Numbers:
  • 201606081
First Posted:
Sep 29, 2016
Last Update Posted:
Dec 2, 2021
Last Verified:
Dec 1, 2021