Trial Outcomes & Findings for Yttrium-90 Radioembolization Using Glass Microspheres (TheraSphere) for Patients With Liver Metastases (NCT NCT01290536)

NCT ID: NCT01290536

Last Updated: 2019-03-01

Results Overview

Adverse effects of treatment with Yttrium-90 glass microspheres (TheraSphere) were collected prospectively for 6 months after each treatment administration.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 42 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2019-03-01

Participant Flow

Between May 2010 and October 2013, 42 adult patients with liver-dominant metastaticd colorectal or neuroendocrine cancer to the liver, or intrahepatic cholangiocarcinoma were enrolled in a prospective single-institution pilot study.

Participant milestones

Measure	Yttrium-90 Radioembolization Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
Overall Study STARTED	42
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Yttrium-90 Radioembolization Using Glass Microspheres (TheraSphere) for Patients With Liver Metastases

Baseline characteristics by cohort

Measure	Yttrium-90 Radioembolization n=42 Participants Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Adverse effects of treatment with Yttrium-90 glass microspheres (TheraSphere) were collected prospectively for 6 months after each treatment administration.

Outcome measures

Measure	Yttrium-90 Radioembolization n=42 Participants Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)	Neuroendocrine - Yttrium-90 Radioembolization Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)	Other Tumors - Yttrium-90 Radioembolization Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
Number of Participants With Adverse Events	42 participants	—	—

SECONDARY outcome

Timeframe: 6 months after treatment

Population: Response data are presented by primary disease sites: Colorectal (mCRC), Neuroendocrine (NET), and all other tumors. One patient with mCRC did not have follow-up cross-sectional imaging. Therefore, radiographic response data was available for 20 of 21 patients with mCRC.

Radiographic response of treated lesions on cross-sectional imaging (computed tomography or magnetic resonance imaging) following treatment with Yttrium-90 glass microspheres (TheraSphere) was assessed based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no change in target lesions; Progressive Disease (PD), increase in target lesions.

Outcome measures

Measure	Yttrium-90 Radioembolization n=20 Participants Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)	Neuroendocrine - Yttrium-90 Radioembolization n=11 Participants Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)	Other Tumors - Yttrium-90 Radioembolization n=10 Participants Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
Radiographic Response Complete Response (CR)	0 participants	0 participants	0 participants
Radiographic Response Partial Response (PR)	4 participants	7 participants	1 participants
Radiographic Response Stable Disease (SD)	12 participants	4 participants	6 participants
Radiographic Response Progressive Disease (PD)	4 participants	0 participants	3 participants

Adverse Events

Yttrium-90 Liver Radioembolization

Serious events: 3 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Measure	Yttrium-90 Liver Radioembolization n=42 participants at risk Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
Blood and lymphatic system disorders hospitalization for carcinoid crisis	9.1% 1/11 • Number of events 1 • 6 months after treatment
Gastrointestinal disorders Vomiting	2.4% 1/42 • Number of events 1 • 6 months after treatment
Gastrointestinal disorders gastric ulcer	2.4% 1/42 • Number of events 1 • 6 months after treatment

Other adverse events

Measure	Yttrium-90 Liver Radioembolization n=42 participants at risk Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
Blood and lymphatic system disorders Lymphopenia	4.8% 2/42 • 6 months after treatment
Blood and lymphatic system disorders Thrombocytopenia	7.1% 3/42 • 6 months after treatment
Cardiac disorders Arrhythmia	2.4% 1/42 • 6 months after treatment
Blood and lymphatic system disorders PT/INR	2.4% 1/42 • 6 months after treatment
General disorders Fatigue	81.0% 34/42 • 6 months after treatment
General disorders Fever	14.3% 6/42 • 6 months after treatment
General disorders Rigors	2.4% 1/42 • 6 months after treatment
General disorders Sweating	16.7% 7/42 • 6 months after treatment
General disorders Flushing	2.4% 1/42 • 6 months after treatment
Skin and subcutaneous tissue disorders Rash	2.4% 1/42 • 6 months after treatment
Gastrointestinal disorders Anorexia	42.9% 18/42 • 6 months after treatment
Gastrointestinal disorders Diarrhea	7.1% 3/42 • 6 months after treatment
General disorders Nausea	47.6% 20/42 • 6 months after treatment
Gastrointestinal disorders Ulcer	2.4% 1/42 • 6 months after treatment
Gastrointestinal disorders Vomiting	19.0% 8/42 • 6 months after treatment
Blood and lymphatic system disorders Edema	2.4% 1/42 • 6 months after treatment
Metabolism and nutrition disorders Albuminemia	35.7% 15/42 • 6 months after treatment
Metabolism and nutrition disorders ALT	33.3% 14/42 • 6 months after treatment
Metabolism and nutrition disorders AST	57.1% 24/42 • 6 months after treatment
Metabolism and nutrition disorders Bilirubin	21.4% 9/42 • 6 months after treatment
Metabolism and nutrition disorders Creatinine	9.5% 4/42 • 6 months after treatment
Musculoskeletal and connective tissue disorders Muscle weakness	2.4% 1/42 • 6 months after treatment
General disorders Abdominal pain	45.2% 19/42 • 6 months after treatment

Additional Information

Nicholas Fidelman, MD

University of California San Francisco

Phone: 1-415-353-1300

Email: Nicholas.Fidelman@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place