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Intra-arterial Y-90 TheraSpheres for Hepatic Metastases From Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeff Geschwind, Yale University
ClinicalTrials.gov Identifier:
NCT01177007
First received: August 2, 2010
Last updated: July 24, 2017
Last verified: July 2017
Results First Received: April 19, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Liver Neoplasms
Intervention: Device: TheraSphere, Yttrium-90 glass Microspheres

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study enrolled patients diagnosed with unresectable hepatic metastases who have failed or were intolerant to at least one line of systemic chemotherapy or liver-directed therapy. Participants were enrolled at Johns Hopkins Hospital with the last patient completed in April 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
TheraSphere TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time

Participant Flow:   Overall Study
    TheraSphere
STARTED   50 
Completed First Y90 Treatment [1]   50 
Completed First Clinical and Imaging [2]   43 
COMPLETED [3]   12 
NOT COMPLETED   38 
Lost to Follow-up                2 
Death                4 
Entered hospice care                5 
Required additional Y90 treatment                6 
Change in treatment modality                21 
[1] Patients completing this milestone were analyzed for survival, safety, and dose outcomes
[2] Patients completing this milestones were assessed for image response outcomes
[3] Patients who completed all 12 months on protocol.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
TheraSphere TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time

Baseline Measures
   TheraSphere 
Overall Participants Analyzed 
[Units: Participants]
 50 
Age 
[Units: Years]
Mean (Full Range)
 59.3 
 (25 to 79) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      19  38.0% 
Male      31  62.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   50 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to Progression (TTP) of the Treated Lesion(s) According to RECIST Criteria   [ Time Frame: Evaluated 4 weeks following each TheraSpheres procedure, and at 2-3 month intervals thereafter. ]

2.  Primary:   Progression-free Survival (PFS) of the Treated Lesion(s) According to RECIST and EASL Criteria   [ Time Frame: 2 years ]

3.  Secondary:   Time to Progression (TTP) of the Treated Lesion(s) According to EASL Criteria   [ Time Frame: Evaluated 4 weeks following each TheraSpheres procedure, and at 2-3 month intervals thereafter. ]

4.  Secondary:   Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) v1.0   [ Time Frame: 12 months ]

5.  Secondary:   Tumor Response by the European Association for the Study of the Liver (EASL) Criteria   [ Time Frame: 12 months ]

6.  Secondary:   Overall Survival (OS)   [ Time Frame: Median follow-up time was 11.41 months (CI: 1.5-33.7) ]

7.  Secondary:   Overall Survival (OS) Rate at 2 Years   [ Time Frame: Up to 2 years ]

8.  Secondary:   Safety as Graded by CTCAE Version 3.0   [ Time Frame: 12 months ]

9.  Secondary:   Mean Radiation Dose Delivered to Total Liver   [ Time Frame: 24 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jean-Francois Geschwind, MD
Organization: Yale University
phone: 203-785-5865
e-mail: jeff.geschwind@yale.edu



Responsible Party: Jeff Geschwind, Yale University
ClinicalTrials.gov Identifier: NCT01177007     History of Changes
Other Study ID Numbers: J09150, NA_00035790
J09150 ( Other Identifier: SKCCC Number )
Study First Received: August 2, 2010
Results First Received: April 19, 2017
Last Updated: July 24, 2017