REgistry of Selective Internal Radiation Therapy in Taiwa... | NCT03292991

Studies
REgistry of Selective Internal Radiation Therapy in TaiwaN (RESIN)

NCT03292991

Sponsor

Taipei Veterans General Hospital, Taiwan

Status

Unknown status

Last Update Posted

Sep 26, 2017Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Hepatocellular Carcinoma

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 9, 2015Actual

Primary Completion Date

Dec 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Aug 4, 2017

First Submission Date that Met QC Criteria

Sep 20, 2017

First Posted Date

Sep 26, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2017

Last Update Posted Date

Sep 26, 2017Actual

Name	Class
Kaohsiung Veterans General Hospital.	OTHER
National Taiwan University Hospital	OTHER
National Cheng-Kung University Hospital	OTHER
China Medical University Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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
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
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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety as per CTCAE 4.03, incidence of AEs and baseline change in liver function paired t-test or Wilcoxon signed rank test.	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.	6 months

Secondary Outcomes

Measure	Description	Time Frame
Overall survival	Overall survival (OS) is determined for all enrolled subjects from Day 0 to the date of death or last contact.	1 year
Overall Response Rate per RECIST 1.1 and mRECIST	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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria, Patients who meet all inclusion criteria will be included:

Males or non-pregnant females, at least 18 years of age (inclusive).
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, Patients who meet any exclusion criteria will be excluded:

Patients known to be hypersensitive to any component of study product.
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

HCC patients or colorectal cancer patients with secondary metastases in the liver.

Sampling Method

Non-Probability Sample

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type