UMIN-CTR Clinical Trial

Basic information
Public title	Relationship between prescription methods and local control rate in stereotactic body radiotherapy for early-stage lung cancer: systematic review
Acronym	Relationship between prescription methods and local control rate in stereotactic body radiotherapy for early-stage lung cancer: systematic review
Scientific Title	Relationship between prescription methods and local control rate in stereotactic body radiotherapy for early-stage lung cancer: systematic review
Scientific Title:Acronym	Relationship between prescription methods and local control rate in stereotactic body radiotherapy for early-stage lung cancer: systematic review
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this systematic review is to clarify whether biologically effective dose at center or periphery of planning target volume is more correlated with local control rate of stereotactic body radiotherapy for early-stage non-small cell lung cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Correlation coefficient between biologically effective dose and local control.
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 studies in which dose prescription methods and local control rate were described. Articles with at least 25 cases and a median follow-up duration of at least 15 months was included.Articles were published as full reports. Non-English reports will be excluded.
Key exclusion criteria	Articles including metastasis or articles which biologically effective dose and local control rate are not determined on a one-to-one basis will be excluded.
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, Ofuna, Kamakura, Kanagawa, Japan
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, Ofuna, Kamakura, Kanagawa, Japan
TEL	0467452111
Homepage URL
Email	eriguchitakahisa@gmail.com

Sponsor
Institute	Ofuna Chuo Hospital
Institute
Department

Funding Source
Organization	N/A
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	N/A
Address	N/A
Tel	N/A
Email	N/A

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	2021 Year 08 Month 01 Day

Related information
URL releasing protocol	N/A
Publication of results	Published

Result
URL related to results and publications	https://www.mdpi.com/2072-6694/14/15/3815
Number of participants that the trial has enrolled	3747
Results	Univariate metaregression revealed that only the central BED significantly correlated with the 3year LC of SBRT for ESNSCLC (p 0.03).
Results date posted	2022 Year 09 Month 02 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Our original plan was to include observational studies that reported the LC of SBRT for peripheral ES-NSCLC.
Participant flow	After excluding reviews, letters, editorials, case reports and series, and laboratory studies, 452 studies remained for the eligibility assessment. After the eligibility assessment, 188 studies were selected for the qualitative synthesis.
Adverse events	Among the 5181 patients, 210 (4.1%) had grade 3 or higher pulmonary toxicities. Grade 3 or higher toxicities other than pulmonary toxicities occurred in 1.2% of patients. Those toxicities rates did not correlate with any type of BED.
Outcome measures	Correlation between BED and local co tool rate.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2021 Year 07 Month 30 Day
Date of IRB	2021 Year 08 Month 01 Day
Anticipated trial start date	2021 Year 08 Month 01 Day
Last follow-up date	2021 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

This study will be conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Study Search We will systematically search PubMed on August 1, 2021. The search formula for PubMed is the followings: (NSCLC[title] OR non-small cell lung cancer[title] OR ((lung[title] OR pulmonary[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 (SBRT[title] OR SRT[title] OR SABR[title] OR stereotactic[title]) AND (local control OR local recurrence OR local relapse OR local progression). Reference lists in the included articles were also checked as hand search. Data Extraction Data will be extracted by the two investigators independently and cross-checked. Data Interpretation Pearson's or Spearman's correlation coefficient between biologically effective dose and local control rate will be calculated.

Management information
Registered date	2021 Year 07 Month 30 Day
Last modified on	2022 Year 09 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050522