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Spots Global Cancer Trial Database for REgistry of Selective Internal Radiation Therapy in TaiwaN (RESIN)

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Trial Identification

Brief Title: REgistry of Selective Internal Radiation Therapy in TaiwaN (RESIN)

Official Title: REgistry of Selective Internal Radiation Therapy in TaiwaN (RESIN)

Study ID: NCT03292991

Interventions

Study Description

Brief Summary: All study objectives will be assessed in HCC patients or colorectal cancer patients with secondary metastases in the liver, respectively.

Detailed Description: All study objectives will be assessed in HCC patients or colorectal cancer patients with secondary metastases in the liver, respectively. 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

Eligibility

Minimum Age: 20 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Taipei Veterans General Hospital, Taipei, , Taiwan

Contact Details

Name: Rheun-Chuan Lee, M.D.

Affiliation: Taipei Veterans General Hospital, Taiwan

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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