Trial Outcomes & Findings for TheraSphere for the Treatment of Liver Metastases (NCT NCT00511862)
NCT ID: NCT00511862
Last Updated: 2021-05-13
Results Overview
Progression per RECIST v 1.0 is defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. A maximum of 5 target lesions per organ are assessed. To assess the impact of a non-systemic local therapy on progression, for the purposes of this trial, hepatic progression was defined as at least a 20% increase in the sum of the longest diameter of target hepatic lesions. Hepatic progression-free survival is the time from the day of first treatment with TheraSphere to determination of hepatic progression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
151 participants
Primary outcome timeframe
From the date of first treatment until date of first documented progression; median patient follow-up 30 months
Results posted on
2021-05-13
Participant Flow
151 patients recruited from January 19, 2007 to October 7, 2009
Patients were assigned to groups on the basis of type of primary cancer - colorectal cancer; neuroendocrine cancer or non-colorectal/non-neuroendocrine. Subjects who unable to receive TheraSphere (target dose 120 Gy) due to vascular shunting to the lungs or GI tract were not enrolled in the study and did not receive yttrium 90 glass microspheres.
Participant milestones
| Measure |
Colorectal Cancer
Colorectal cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
|
Neuroendocrine Cancer
Neuroendocrine cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
|
Non-Colorectal/Non-neuroendocrine
Patients with liver metastatic disease not arising from colorectal cancer or neuroendocrine cancer, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
|
|---|---|---|---|
|
Overall Study
STARTED
|
61
|
43
|
47
|
|
Overall Study
COMPLETED
|
61
|
43
|
47
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TheraSphere for the Treatment of Liver Metastases
Baseline characteristics by cohort
| Measure |
Colorectal Cancer
n=61 Participants
colorectal cancer patients with liver metastatic disease, refractory to standard of care therapy
|
Neuroendocrine Cancer
n=43 Participants
neuroendocrine cancer patients with liver metastatic disease, refractory to standard of care therapy
|
Non-Colorectal/Non-neuroendocrine
n=47 Participants
patients with liver metastatic disease not arising from colorectal cancer or neuroendocrine cancer, refractory to standard of care therapy
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
32 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 10.92 • n=5 Participants
|
61.8 years
STANDARD_DEVIATION 13.71 • n=7 Participants
|
66.1 years
STANDARD_DEVIATION 8.52 • n=5 Participants
|
63.7 years
STANDARD_DEVIATION 11.21 • n=4 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=5 Participants
|
43 participants
n=7 Participants
|
47 participants
n=5 Participants
|
151 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From the date of first treatment until date of first documented progression; median patient follow-up 30 monthsPopulation: Patients receiving at least one TheraSphere treatment with images evaluable by RECIST
Progression per RECIST v 1.0 is defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. A maximum of 5 target lesions per organ are assessed. To assess the impact of a non-systemic local therapy on progression, for the purposes of this trial, hepatic progression was defined as at least a 20% increase in the sum of the longest diameter of target hepatic lesions. Hepatic progression-free survival is the time from the day of first treatment with TheraSphere to determination of hepatic progression.
Outcome measures
| Measure |
Colorectal Cancer
n=58 Participants
Colorectal cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
|
Neuroendocrine Cancer
n=43 Participants
Neuroendocrine cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
|
Non-Colorectal/Non-neuroendocrine
n=46 Participants
Patients with liver metastatic disease not arising from colorectal cancer or neuroendocrine cancer, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
|
All Patients
n=147 Participants
All patients in colorectal cancer, neuroendocrine cancer and non-colorectal/non-neuroendocrine groups
|
|---|---|---|---|---|
|
Hepatic Progression-free Survival According to Response Evaluation Criterian in Solid Tumors (RECIST)
|
3.0 Months
Interval 2.0 to 5.8
|
17.9 Months
Interval 13.5 to 19.5
|
2.9 Months
Interval 1.3 to 3.3
|
3.4 Months
Interval 3.0 to 6.5
|
SECONDARY outcome
Timeframe: Time from first TheraSphere treatment to death; median follow up 30 monthsPopulation: In the neuroendocrine group, a median overall survival was not achieved so a post-hoc analysis of 2 year survival was performed in Outcome Measure 3.
Duration of survival from date of first TheraSphere treatment to date of death or censored to last known date alive.
Outcome measures
| Measure |
Colorectal Cancer
n=61 Participants
Colorectal cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
|
Neuroendocrine Cancer
n=47 Participants
Neuroendocrine cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
|
Non-Colorectal/Non-neuroendocrine
n=151 Participants
Patients with liver metastatic disease not arising from colorectal cancer or neuroendocrine cancer, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
|
All Patients
All patients in colorectal cancer, neuroendocrine cancer and non-colorectal/non-neuroendocrine groups
|
|---|---|---|---|---|
|
Overall Survival
|
8.8 Months
Interval 6.6 to 11.9
|
10.4 Months
Interval 6.6 to 14.6
|
13.6 Months
Interval 11.1 to 16.1
|
—
|
POST_HOC outcome
Timeframe: 24 months from treatmentThe percentage of patients in the neuroendocrine group alive at 2 years
Outcome measures
| Measure |
Colorectal Cancer
n=43 Participants
Colorectal cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
|
Neuroendocrine Cancer
Neuroendocrine cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
|
Non-Colorectal/Non-neuroendocrine
Patients with liver metastatic disease not arising from colorectal cancer or neuroendocrine cancer, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
|
All Patients
All patients in colorectal cancer, neuroendocrine cancer and non-colorectal/non-neuroendocrine groups
|
|---|---|---|---|---|
|
2 Year Survival
|
79.1 percentage of treated subjects
|
—
|
—
|
—
|
Adverse Events
TheraSphere
Serious events: 21 serious events
Other events: 139 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TheraSphere
n=151 participants at risk
total population receiving at least one TheraSphere treatment
|
|---|---|
|
Nervous system disorders
Abdominal or epigastric pain
|
3.3%
5/151 • Number of events 5 • All adverse events collected for 3 months, device-related adverse events captured to month 18
|
|
General disorders
Death
|
1.3%
2/151 • Number of events 2 • All adverse events collected for 3 months, device-related adverse events captured to month 18
|
|
Blood and lymphatic system disorders
Decreased platelets
|
0.66%
1/151 • Number of events 1 • All adverse events collected for 3 months, device-related adverse events captured to month 18
|
|
Gastrointestinal disorders
Dehydration
|
0.66%
1/151 • Number of events 1 • All adverse events collected for 3 months, device-related adverse events captured to month 18
|
|
Gastrointestinal disorders
Esophagial varices
|
0.66%
1/151 • Number of events 1 • All adverse events collected for 3 months, device-related adverse events captured to month 18
|
|
Blood and lymphatic system disorders
GI hemorrhage
|
0.66%
1/151 • Number of events 1 • All adverse events collected for 3 months, device-related adverse events captured to month 18
|
|
Gastrointestinal disorders
GI ulcer
|
1.3%
2/151 • Number of events 2 • All adverse events collected for 3 months, device-related adverse events captured to month 18
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
0.66%
1/151 • Number of events 1 • All adverse events collected for 3 months, device-related adverse events captured to month 18
|
|
Infections and infestations
Infection
|
0.66%
1/151 • Number of events 1 • All adverse events collected for 3 months, device-related adverse events captured to month 18
|
|
Hepatobiliary disorders
Liver dysfunction/failure
|
1.3%
2/151 • Number of events 2 • All adverse events collected for 3 months, device-related adverse events captured to month 18
|
|
Gastrointestinal disorders
Nausea
|
1.3%
2/151 • Number of events 2 • All adverse events collected for 3 months, device-related adverse events captured to month 18
|
|
Gastrointestinal disorders
Obstruction
|
1.3%
2/151 • Number of events 2 • All adverse events collected for 3 months, device-related adverse events captured to month 18
|
|
Renal and urinary disorders
Renal failure
|
0.66%
1/151 • Number of events 1 • All adverse events collected for 3 months, device-related adverse events captured to month 18
|
|
Vascular disorders
Thrombosis/embolus
|
0.66%
1/151 • Number of events 1 • All adverse events collected for 3 months, device-related adverse events captured to month 18
|
|
Injury, poisoning and procedural complications
Vessel injury - lower extremity artery
|
0.66%
1/151 • Number of events 1 • All adverse events collected for 3 months, device-related adverse events captured to month 18
|
Other adverse events
| Measure |
TheraSphere
n=151 participants at risk
total population receiving at least one TheraSphere treatment
|
|---|---|
|
Metabolism and nutrition disorders
ALT > ULN
|
17.2%
26/151 • Number of events 26 • All adverse events collected for 3 months, device-related adverse events captured to month 18
|
|
Metabolism and nutrition disorders
AST >ULN
|
23.8%
36/151 • Number of events 36 • All adverse events collected for 3 months, device-related adverse events captured to month 18
|
|
Metabolism and nutrition disorders
Alkaline phosphatase >ULN
|
37.1%
56/151 • Number of events 56 • All adverse events collected for 3 months, device-related adverse events captured to month 18
|
|
Metabolism and nutrition disorders
Anorexia
|
23.8%
36/151 • Number of events 36 • All adverse events collected for 3 months, device-related adverse events captured to month 18
|
|
Metabolism and nutrition disorders
Bilirubin >ULN
|
12.6%
19/151 • Number of events 19 • All adverse events collected for 3 months, device-related adverse events captured to month 18
|
|
Gastrointestinal disorders
Constipation
|
7.3%
11/151 • Number of events 11 • All adverse events collected for 3 months, device-related adverse events captured to month 18
|
|
General disorders
Fatigue
|
60.3%
91/151 • Number of events 91 • All adverse events collected for 3 months, device-related adverse events captured to month 18
|
|
Metabolism and nutrition disorders
Hypoalbuminemia < LLN
|
12.6%
19/151 • Number of events 19 • All adverse events collected for 3 months, device-related adverse events captured to month 18
|
|
Blood and lymphatic system disorders
Lymphopenia
|
10.6%
16/151 • Number of events 16 • All adverse events collected for 3 months, device-related adverse events captured to month 18
|
|
Gastrointestinal disorders
Nausea
|
39.1%
59/151 • Number of events 59 • All adverse events collected for 3 months, device-related adverse events captured to month 18
|
|
Nervous system disorders
Pain
|
41.1%
62/151 • Number of events 62 • All adverse events collected for 3 months, device-related adverse events captured to month 18
|
|
Gastrointestinal disorders
Vomitting
|
12.6%
19/151 • Number of events 19 • All adverse events collected for 3 months, device-related adverse events captured to month 18
|
|
General disorders
Weight loss
|
7.3%
11/151 • Number of events 11 • All adverse events collected for 3 months, device-related adverse events captured to month 18
|
Additional Information
Director of Clinical Operations
BTG International Canada Inc.
Phone: 613-801-1880
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place