UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042813 |
|---|---|
| Receipt number | R000048859 |
| Scientific Title | Comparison between stereotactic body radiotherapy and transcatheter arterial chemoembolization for hepatocellular carcinoma: Meta-analysis and systematic review. |
| Date of disclosure of the study information | 2020/12/22 |
| Last modified on | 2022/07/29 15:43:37 |
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Basic information
Public title
Comparison between stereotactic body radiotherapy and transcatheter arterial chemoembolization for hepatocellular carcinoma: Meta-analysis and systematic review.
Acronym
Comparison between stereotactic body radiotherapy and transcatheter arterial chemoembolization for hepatocellular carcinoma: Meta-analysis and systematic review.
Scientific Title
Comparison between stereotactic body radiotherapy and transcatheter arterial chemoembolization for hepatocellular carcinoma: Meta-analysis and systematic review.
Scientific Title:Acronym
Comparison between stereotactic body radiotherapy and transcatheter arterial chemoembolization for hepatocellular carcinoma: Meta-analysis and systematic review.
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | 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 transcatheter 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. In recent years, there are several retrospective studies which compared SBRT and TACE using propensity score analysis. Aim of current meta-analysis is to summarize data from quality studies compared SBRT and TACE using propensity score analysis.
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 analysis that compared SBRT and TACE 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
247-0056
Address
6-2-24, Ofuna, Kamakura
TEL
0467-45-2111
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
247-0056
Address
6-2-24, Ofuna, Kamakura
TEL
0467-45-2111
Homepage URL
eriguchitakahisa@gmail.com
Sponsor or person
Institute
Ofuna Chuo Hospital
Institute
Department
Personal name
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
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 | 12 | Month | 22 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
0
Results
N/A
Results date posted
| 2022 | Year | 07 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
N/A
Participant flow
N/A
Adverse events
N/A
Outcome measures
N/A
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2020 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 22 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 22 | 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 December 22,2020. The search strategy for PubMed will be as follows:
(hepatoma OR hepatomas OR HCC OR ((hepatocellular OR hepatic OR liver) AND (cancer OR carcinoma OR malignancy OR tumor OR neoplasm OR neoplasms OR carcinomas OR malignancies))) AND (TACE OR TAE OR (transcatheter arterial chemoembolization) OR (transarterial chemoembolization)) AND (SBRT OR SRT OR SABR OR stereotactic OR radiotherapy OR radiation OR irradiation) AND (randomized OR randomly 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 | 12 | Month | 22 | Day |
Last modified on
| 2022 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048859
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
