REgistry of Selective Internal Radiation Therapy in TaiwaN (RESIN)
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|ClinicalTrials.gov Identifier: NCT03292991|
Recruitment Status : Recruiting
First Posted : September 26, 2017
Last Update Posted : September 26, 2017
|Condition or disease|
All study objectives will be assessed in HCC patients or colorectal cancer patients with secondary metastases in the liver, respectively.
To observe the safety of SIR-Spheres® microspheres therapy (SIRT)by,
- Adverse events and serious adverse events (non-specific and radiation specific)
- Changes in liver function parameters
- To observe the efficacy of SIR-Spheres® microspheres therapy by, assessing the best overall response rate after SIRT
To observe the efficacy of SIRT by,
- Overall survival (OS)
- Overall/objective response rate (ORR)
- Time-to-liver progression
- Progression-free survival
To observe the changes in clinical presentation after SIRT by,
- ECOG score
- Child-Pugh score
- Percentage of subjects with down-staging or down-sizing of treated lesion to resection, transplantation, or radiofrequency ablation (RFA)
To observe the practice pattern of SIRT by,
- Median dosage (GBq)
- Number of SIRT sessions received by subjects
To explore prognostic factors for disease progression after SIRT by comparing the following parameters:
- Number of tumors in subjects prior to SIRT
- Median tumor size in subjects prior to SIRT
- Location of tumor in subjects treated with SIRT (hepatic segment or lobe)
- Number of prior TACE treatment in subjects
- Antiviral therapy subjects HCC
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||REgistry of Selective Internal Radiation Therapy in TaiwaN (RESIN)|
|Actual Study Start Date :||June 9, 2015|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
- Safety as per CTCAE 4.03, incidence of AEs and baseline change in liver function paired t-test or Wilcoxon signed rank test. [ Time Frame: 6 months ]Toxicity will be accessed according to CTCAE v4.03. The incidence of adverse events will be summarized and the change in baseline liver function will be assessed by paired t-test or Wilcoxon signed rank test.
- Overall survival [ Time Frame: 1 year ]Overall survival (OS) is determined for all enrolled subjects from Day 0 to the date of death or last contact.
- Overall Response Rate per RECIST 1.1 and mRECIST [ Time Frame: 1 year ]
Liver tumor assessments for CRC will be evaluated by RECIST v1.1; and tumor assessments for HCC will be evaluated by mRECIST.
- Objective Response Rate is defined as the proportion of subjects with tumor size reduction (i.e. the combined proportion of subjects with CR and PR) from Day 0 until documented tumor progression.
- Time-to-progression per RECIST 1.1 and mRECIST [ Time Frame: 1 year ]The time-to-progression (TTP) is calculated by the time from Day 0 to the date of disease progression (PD).
- Time-to-liver progression per RECIST 1.1 and mRECIST [ Time Frame: 1 year ]The time-to-liver progression is calculated by the time from Day 0 to the date of tumor progression (PD) in intrahepatic lesions.
- Progression-free survival [ Time Frame: 1 year ]Progression free survival (PFS) is determined for all enrolled patients from Day 0 until tumor progression or patient death.
- Liver resection rate [ Time Frame: 1 year ]Patients will be assessed for suitability for liver resection every study visit during the study period.
- Liver transplantation rate [ Time Frame: 1 year ]Patients will be assessed for suitability for liver transplantation every study visit during the study period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03292991
|Contact: Rheun-Chuan Lee, M.D.||+886-2-28712121 ext firstname.lastname@example.org|
|Taipei Veterans General Hospital||Recruiting|
|Taipei, Taiwan, 11217|
|Contact: Rheun-Chuan Lee, M.D. +886-2-28712121 ext 3069 email@example.com|
|Principal Investigator:||Rheun-Chuan Lee, M.D.||Taipei Veterans General Hospital, Taiwan|