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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041927
Receipt No. R000047710
Scientific Title Comparison between stereotactic body radiotherapy and radiofrequency ablation for hepatocellular carcinoma: Meta-analysis and systematic review.
Date of disclosure of the study information 2020/10/01
Last modified on 2020/09/28

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Basic information
Public title Comparison between stereotactic body radiotherapy and radiofrequency ablation for hepatocellular carcinoma: Meta-analysis and systematic review.
Acronym Comparison between stereotactic body radiotherapy and radiofrequency ablation for hepatocellular carcinoma: Meta-analysis and systematic review.
Scientific Title Comparison between stereotactic body radiotherapy and radiofrequency ablation for hepatocellular carcinoma: Meta-analysis and systematic review.
Scientific Title:Acronym Comparison between stereotactic body radiotherapy and radiofrequency ablation for hepatocellular carcinoma: Meta-analysis and systematic review.
Region
Japan

Condition
Condition Hepatocellular carcinoma
Classification by specialty
Gastroenterology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 In the Barcelona Clinic Liver Cancer staging and treatment strategy (BCLC) guideline, surgery, radiofrequency ablation (RFA), and trans-arterial chemoembolization (TACE) are considered as standard treatment for hepatocellular carcinoma (HCC). Although stereotactic body radiotherapy (SBRT) has been recognized as novel local therapy for HCC, SBRT is still not mentioned in BCLC guideline due to lack of randomized control trials. Recently, meta-analysis which compared SBRT and RFA for HCC has published. However, reports analyzed in the meta-analysis were heterogeneous in quality. In recent years, there are several retrospective studies which compared SBRT and RFA using propensity score matching (PSM). Aim of current meta-analysis is to summarize data from quality studies compared SBRT and RFA using PSM.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hazard ratio of overall survival
Key secondary outcomes

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria We will include observational studies using propensity score matching that compared SBRT and RFA for HCC. Articles were published as full reports, brief reports, or conference abstracts, regardless of their primary end point. Non-English reports were excluded.
Key exclusion criteria NA
Target sample size

Research contact person
Name of lead principal investigator
1st name Takahisa
Middle name
Last name Eriguchi
Organization Ofuna Chuo Hospital
Division name Radiation Oncology Center
Zip code 2470056
Address 6-2-24
TEL 0467452111
Email eriguchitakahisa@gmail.com

Public contact
Name of contact person
1st name Takahisa
Middle name
Last name Eriguchi
Organization Ofuna Chuo Hospital
Division name Radiation Oncology Center
Zip code 2470056
Address 6-2-24
TEL 0467452111
Homepage URL
Email eriguchitakahisa@gmail.com

Sponsor
Institute Ofuna Chuo Hospital
Institute
Department

Funding Source
Organization NA
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization NA
Address NA
Tel 0467452111
Email eriguchitakahisa@gmail.com

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2020 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 10 Month 01 Day
Last follow-up date
2020 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study Search
We will systematically search PubMed, the Cochrane database, EMBASE, and Web of Science as of October 1, 2020. The search strategy for PubMed will be as follows:
(hepatoma[title] OR hepatomas[title] OR HCC[title] OR ((hepatocellular[title] OR hepatic[title] OR liver[title]) AND (cancer[title] OR carcinoma[title] OR malignancy[title] OR tumor[title] OR neoplasm[title] OR neoplasms[title] OR carcinomas[title] OR malignancies[title]))) AND (RFA OR ((radiofrequency OR thermal) AND (ablation OR ablative))) AND (SBRT OR SRT OR SABR OR stereotactic OR radiotherapy OR radiation OR irradiation) AND (randomized OR randomized OR RCT OR randomly OR phase III OR phase 3 OR propensity OR PSM OR Inverse probability of treatment weighting OR Doubly Robustness)

Reference lists in the included articles and review articles will be also hand searched.


Data synthesis
HR from propensity score matched studies will be pooled. Prior to generic inverse variance meta-analysis using RevMan 5.0 (Cochrane Collaboration, London, UK), HR will be log converted.
Subgroup analyses which focus on liver function will be performed.
Statistical significance will be judged by P < 0.05.

Management information
Registered date
2020 Year 09 Month 29 Day
Last modified on
2020 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047710

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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