Trial Outcomes & Findings for Study Of Intrahepatic Arterial Injection of 90-Y Glass Microspheres for Cholangiocarcinoma (NCT NCT01253148)
NCT ID: NCT01253148
Last Updated: 2017-03-22
Results Overview
PFS is defined as the duration of time from enrollment to time of progression or death from any cause. Progression will be defined as progressive disease in the treated lobe. If progression is seen in a treated lobe, this will be considered a treatment failure. Progressive Disease (PD) according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) Version 1.1.: At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
End of post treatment follow-up period of 20 months
Results posted on
2017-03-22
Participant Flow
Twenty-five participants were enrolled at Moffitt Cancer Center between 2010 and 2013.
Participant milestones
| Measure |
Arterial Injection of 90-Y Microspheres
Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma
TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Of Intrahepatic Arterial Injection of 90-Y Glass Microspheres for Cholangiocarcinoma
Baseline characteristics by cohort
| Measure |
Arterial Injection of 90-Y Microspheres
n=25 Participants
Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma
TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=5 Participants
|
|
Age, Continuous
|
76 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: End of post treatment follow-up period of 20 monthsPopulation: All participants
PFS is defined as the duration of time from enrollment to time of progression or death from any cause. Progression will be defined as progressive disease in the treated lobe. If progression is seen in a treated lobe, this will be considered a treatment failure. Progressive Disease (PD) according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) Version 1.1.: At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Arterial Injection of 90-Y Microspheres
n=25 Participants
Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma
TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver.
|
|---|---|
|
Median Progression Free Survival (PFS)
|
6 months
Interval 4.0 to 12.0
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: All participants
OS is defined as the duration of time from enrollment to time of death from any cause.
Outcome measures
| Measure |
Arterial Injection of 90-Y Microspheres
n=25 Participants
Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma
TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver.
|
|---|---|
|
Median Overall Survival (OS)
|
22 months
Interval 10.0 to
Upper limit not reached
|
SECONDARY outcome
Timeframe: End of post treatment follow-up period of up to 20 monthsPopulation: All participants
Tumor Response according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Complete Response (CR): Complete disappearance of all target and non-target lesions; no new lesions. Partial Response (PR): Applies only to patients with at least one measurable lesion; Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions; No unequivocal progression of non-measurable disease; No new lesions.
Outcome measures
| Measure |
Arterial Injection of 90-Y Microspheres
n=25 Participants
Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma
TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver.
|
|---|---|
|
Overall Response Rate (ORR)
|
56 percentage of participants
|
Adverse Events
Arterial Injection of 90-Y Microspheres
Serious events: 11 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arterial Injection of 90-Y Microspheres
n=25 participants at risk
Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma
TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.0%
1/25 • Number of events 1 • 4 years, 5 months
|
|
Cardiac disorders
Atrial fibrillation
|
4.0%
1/25 • Number of events 1 • 4 years, 5 months
|
|
Cardiac disorders
Myocardial infarction
|
4.0%
1/25 • Number of events 1 • 4 years, 5 months
|
|
Cardiac disorders
Sinus tachycardia
|
4.0%
1/25 • Number of events 1 • 4 years, 5 months
|
|
Cardiac disorders
Ventricular tachycardia
|
4.0%
1/25 • Number of events 1 • 4 years, 5 months
|
|
Gastrointestinal disorders
Abdominal pain
|
12.0%
3/25 • Number of events 3 • 4 years, 5 months
|
|
Gastrointestinal disorders
Bloating
|
4.0%
1/25 • Number of events 1 • 4 years, 5 months
|
|
Gastrointestinal disorders
Constipation
|
4.0%
1/25 • Number of events 1 • 4 years, 5 months
|
|
Gastrointestinal disorders
Dry mouth
|
4.0%
1/25 • Number of events 1 • 4 years, 5 months
|
|
Gastrointestinal disorders
Dyspepsia
|
4.0%
1/25 • Number of events 1 • 4 years, 5 months
|
|
Gastrointestinal disorders
Flatulence
|
4.0%
1/25 • Number of events 1 • 4 years, 5 months
|
|
Gastrointestinal disorders
Nausea
|
8.0%
2/25 • Number of events 2 • 4 years, 5 months
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
2/25 • Number of events 2 • 4 years, 5 months
|
|
General disorders
Chills
|
8.0%
2/25 • Number of events 2 • 4 years, 5 months
|
|
General disorders
Death NOS
|
4.0%
1/25 • Number of events 1 • 4 years, 5 months
|
|
General disorders
Edema
|
4.0%
1/25 • Number of events 1 • 4 years, 5 months
|
|
General disorders
Fatigue
|
8.0%
2/25 • Number of events 2 • 4 years, 5 months
|
|
General disorders
Fever
|
8.0%
2/25 • Number of events 2 • 4 years, 5 months
|
|
General disorders
Non-cardiac chest pain
|
4.0%
1/25 • Number of events 1 • 4 years, 5 months
|
|
Infections and infestations
Infections and infestations - Other, urosepsis
|
4.0%
1/25 • Number of events 1 • 4 years, 5 months
|
|
Infections and infestations
Lung infection
|
4.0%
1/25 • Number of events 1 • 4 years, 5 months
|
|
Infections and infestations
Sepsis
|
8.0%
2/25 • Number of events 2 • 4 years, 5 months
|
|
Infections and infestations
Skin infection
|
4.0%
1/25 • Number of events 1 • 4 years, 5 months
|
|
Injury, poisoning and procedural complications
Bruising
|
4.0%
1/25 • Number of events 1 • 4 years, 5 months
|
|
Investigations
Alanine aminotransferase increased
|
4.0%
1/25 • Number of events 2 • 4 years, 5 months
|
|
Investigations
Alkaline phosphatase increased
|
8.0%
2/25 • Number of events 3 • 4 years, 5 months
|
|
Investigations
Aspartate aminotransferase increased
|
4.0%
1/25 • Number of events 2 • 4 years, 5 months
|
|
Investigations
Blood bilirubin increased
|
8.0%
2/25 • Number of events 3 • 4 years, 5 months
|
|
Investigations
Platelet count decreased
|
8.0%
2/25 • Number of events 2 • 4 years, 5 months
|
|
Metabolism and nutrition disorders
Dehydration
|
4.0%
1/25 • Number of events 1 • 4 years, 5 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.0%
1/25 • Number of events 1 • 4 years, 5 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
8.0%
2/25 • Number of events 2 • 4 years, 5 months
|
|
Nervous system disorders
Headache
|
4.0%
1/25 • Number of events 1 • 4 years, 5 months
|
|
Nervous system disorders
Lethargy
|
4.0%
1/25 • Number of events 1 • 4 years, 5 months
|
|
Psychiatric disorders
Confusion
|
4.0%
1/25 • Number of events 1 • 4 years, 5 months
|
|
Renal and urinary disorders
Urine discoloration
|
4.0%
1/25 • Number of events 1 • 4 years, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.0%
1/25 • Number of events 1 • 4 years, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.0%
2/25 • Number of events 2 • 4 years, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.0%
3/25 • Number of events 3 • 4 years, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
4.0%
1/25 • Number of events 1 • 4 years, 5 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.0%
1/25 • Number of events 1 • 4 years, 5 months
|
|
Vascular disorders
Hypotension
|
4.0%
1/25 • Number of events 1 • 4 years, 5 months
|
|
Vascular disorders
Thromboembolic event
|
8.0%
2/25 • Number of events 3 • 4 years, 5 months
|
Other adverse events
| Measure |
Arterial Injection of 90-Y Microspheres
n=25 participants at risk
Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma
TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver.
|
|---|---|
|
General disorders
Fatigue
|
92.0%
23/25 • Number of events 34 • 4 years, 5 months
|
|
General disorders
Flu like symptoms
|
28.0%
7/25 • Number of events 8 • 4 years, 5 months
|
|
General disorders
Edema limbs
|
20.0%
5/25 • Number of events 6 • 4 years, 5 months
|
|
General disorders
Chills
|
12.0%
3/25 • Number of events 4 • 4 years, 5 months
|
|
General disorders
Pain
|
12.0%
3/25 • Number of events 3 • 4 years, 5 months
|
|
General disorders
Fever
|
8.0%
2/25 • Number of events 2 • 4 years, 5 months
|
|
Investigations
Lymphocyte count decreased
|
92.0%
23/25 • Number of events 37 • 4 years, 5 months
|
|
Investigations
Alkaline phosphatase increased
|
80.0%
20/25 • Number of events 27 • 4 years, 5 months
|
|
Investigations
Aspartate aminotransferase increased
|
28.0%
7/25 • Number of events 8 • 4 years, 5 months
|
|
Investigations
Platelet count decreased
|
24.0%
6/25 • Number of events 8 • 4 years, 5 months
|
|
Investigations
Weight loss
|
24.0%
6/25 • Number of events 6 • 4 years, 5 months
|
|
Investigations
Blood bilirubin increased
|
16.0%
4/25 • Number of events 6 • 4 years, 5 months
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
5/25 • Number of events 6 • 4 years, 5 months
|
|
Investigations
White blood cell decreased
|
16.0%
4/25 • Number of events 5 • 4 years, 5 months
|
|
Investigations
Activated partial thromboplastin time prolonged
|
12.0%
3/25 • Number of events 4 • 4 years, 5 months
|
|
Investigations
Creatinine increased
|
12.0%
3/25 • Number of events 4 • 4 years, 5 months
|
|
Investigations
INR increased
|
8.0%
2/25 • Number of events 2 • 4 years, 5 months
|
|
Gastrointestinal disorders
Abdominal pain
|
80.0%
20/25 • Number of events 30 • 4 years, 5 months
|
|
Gastrointestinal disorders
Nausea
|
72.0%
18/25 • Number of events 28 • 4 years, 5 months
|
|
Gastrointestinal disorders
Dyspepsia
|
24.0%
6/25 • Number of events 7 • 4 years, 5 months
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
5/25 • Number of events 6 • 4 years, 5 months
|
|
Gastrointestinal disorders
Constipation
|
20.0%
5/25 • Number of events 6 • 4 years, 5 months
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
5/25 • Number of events 6 • 4 years, 5 months
|
|
Gastrointestinal disorders
Abdominal distension
|
12.0%
3/25 • Number of events 4 • 4 years, 5 months
|
|
Gastrointestinal disorders
Flatulence
|
8.0%
2/25 • Number of events 2 • 4 years, 5 months
|
|
Gastrointestinal disorders
Ascites
|
8.0%
2/25 • Number of events 2 • 4 years, 5 months
|
|
Gastrointestinal disorders
Bloating
|
8.0%
2/25 • Number of events 2 • 4 years, 5 months
|
|
Metabolism and nutrition disorders
Anorexia
|
52.0%
13/25 • Number of events 16 • 4 years, 5 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
44.0%
11/25 • Number of events 12 • 4 years, 5 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
36.0%
9/25 • Number of events 9 • 4 years, 5 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
24.0%
6/25 • Number of events 9 • 4 years, 5 months
|
|
Metabolism and nutrition disorders
Dehydration
|
16.0%
4/25 • Number of events 4 • 4 years, 5 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.0%
2/25 • Number of events 2 • 4 years, 5 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.0%
2/25 • Number of events 2 • 4 years, 5 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
8.0%
2/25 • Number of events 2 • 4 years, 5 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.0%
2/25 • Number of events 3 • 4 years, 5 months
|
|
Blood and lymphatic system disorders
Anemia
|
60.0%
15/25 • Number of events 18 • 4 years, 5 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.0%
3/25 • Number of events 3 • 4 years, 5 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
8.0%
2/25 • Number of events 2 • 4 years, 5 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
2/25 • Number of events 2 • 4 years, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.0%
3/25 • Number of events 3 • 4 years, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.0%
3/25 • Number of events 3 • 4 years, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.0%
3/25 • Number of events 3 • 4 years, 5 months
|
|
Vascular disorders
Hot flashes
|
16.0%
4/25 • Number of events 5 • 4 years, 5 months
|
|
Vascular disorders
Hypertension
|
12.0%
3/25 • Number of events 3 • 4 years, 5 months
|
|
Vascular disorders
Thromboembolic event
|
8.0%
2/25 • Number of events 2 • 4 years, 5 months
|
Additional Information
Sarah Hoffe, M.D.
H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-3814
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place