REgistry of Selective Internal Radiation Therapy in TaiwaN (RESIN)
NCT ID: NCT03292991
Last Updated: 2017-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2015-06-09
2019-12-31
Brief Summary
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Detailed Description
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1. Primary objective:
* 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
2. Secondary objectives:
* To observe the efficacy of SIRT by,
* Overall survival (OS)
* Overall/objective response rate (ORR)
* Time-to-progression
* 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
3. Exploratory objectives:
* 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
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patients with clinically confirmed hepatocellular carcinoma (HCC) OR adenocarcinoma of colon/rectum with liver metastasis.
* Patients with liver dominant disease.
* Tumor burden ≤ 70% of total liver volume.
* HCC patients with child-Pugh Score class A or B.
* HCC patients with Barcelona-Clinic Liver Cancer (BCLC) stage A-C.
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
* Patients who are unsuitable for resection or immediate liver transplantation or who cannot be optimally treated with local ablation.
* Patients who have provided written informed consent.
Exclusion Criteria
* Female patients who are pregnant or lactating. Women of child bearing potential who disagree to practice medically recognized birth control methods throughout the study (from Screening to approximately 6 months post SIRT). Medically recognized birth control methods include hormonal contraceptives, intrauterine device/IUD, barrier device, or abstinence. With the exception of women who had been surgically sterilized (defined as having undergone hysterectomy or bilateral oophorectomy or bilateral salpingectomy; tubal ligation alone is not considered sufficient), or one year post-menopausal.
Withdrawal criteria:
* Patients consent withdrawal.
* Lost to follow-up for 2 consecutive visits.
20 Years
ALL
No
Sponsors
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Kaohsiung Veterans General Hospital.
OTHER
National Taiwan University Hospital
OTHER
National Cheng-Kung University Hospital
OTHER
China Medical University Hospital
OTHER
Chang Gung Memorial Hospital
OTHER
Mackay Memorial Hospital
OTHER
Taipei Veterans General Hospital, Taiwan
OTHER_GOV
Responsible Party
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vghtpe user
Principal Investigator, Dr. Rheun-Chuan Lee
Principal Investigators
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Rheun-Chuan Lee, M.D.
Role: PRINCIPAL_INVESTIGATOR
Taipei Veterans General Hospital, Taiwan
Locations
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Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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QCR14021
Identifier Type: -
Identifier Source: org_study_id