UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046913 |
|---|---|
| Receipt number | R000053514 |
| Scientific Title | Relationship between local control rate and overall survival rate in stereotactic body radiotherapy for early-stage lung cancer: systematic review |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2023/08/17 09:47:58 |
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Basic information
Public title
Relationship between local control rate and overall survival rate in stereotactic body radiotherapy for early-stage lung cancer: systematic review
Acronym
Relationship between local control rate and overall survival rate in stereotactic body radiotherapy for early-stage lung cancer: systematic review
Scientific Title
Relationship between local control rate and overall survival rate in stereotactic body radiotherapy for early-stage lung cancer: systematic review
Scientific Title:Acronym
Relationship between local control rate and overall survival 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 local control is correlated with overall survival rate in 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
Meta-regression analysis to investigate correlation coefficient between local control and overall survival
Key secondary outcomes
Meta-regression analysis to investigate correlation coefficient between local control and outcomes including cancer-specific survival, distant metastases-free survival, and disease-free survival
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
Patients with NSCLC staged as T1-2N0 treated with SBRT are aimed for the study. 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 12 months was included.Articles were published as full reports. Non-English reports will be excluded.The reports are permitted for centrally located tumors, or T3 or T4 tumors consisted of less than 30% of the entire study population.
Key exclusion criteria
Articles including metastasis or articles which overall survival and local control rates are not determined on a one-to-one basis will be excluded.
Studies involving patients with metastatic lung tumors, postoperative recurrence or lymph node metastases, or studies restricted to elderly patients are excluded.
The reports were excluded if patients are recruited for a certain property of the tumor or patients characteristics such as pathology, ground-glass opacity, operability, or interstitial pneumonia.
Data that only reported outcomes for specific patient groups (e.g., operable vs. inoperable) or tumor groups (e.g., histologically proven vs. unproven) and for which no overall outcome was given are excluded.
Studies including particle therapy and concurrent chemotherapy are excluded.
Concurrent chemotherapy is not permitted.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Naoko |
| Middle name | |
| Last name | Sanuki |
Organization
Ofuna Chuo Hospital
Division name
Radiation Oncology Center
Zip code
2470056
Address
6-2-24, Ofuna, Kamakura, Kanagawa, Japan
TEL
0467452111
naokosanuki@icloud.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Naoko |
Organization
Ofuna Chuo Hospital
Division name
Radiation Oncology Center
Zip code
2470056
Address
6-2-24, Ofuna, Kamakura, Kanagawa, Japan
TEL
0467452111
Homepage URL
naokosanuki@icloud.com
Sponsor or person
Institute
Ofuna Chuo Hospital
Institute
Department
Personal name
Funding Source
Organization
Self Funding
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
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
大船中央病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/37024056/
Publication of results
Unpublished
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/37024056/
Number of participants that the trial has enrolled
13435
Results
Purpose: Local control (LC) is an important outcome of local cancer therapy, besides overall survival (OS). We conducted a comprehensive literature search to investigate whether a high LC rate contributes to good OS in radiotherapy for early-stage non-small cell lung cancer (ES-NSCLC).
Conclusions: Three-year LC was correlated with three-year OS in patients receiving radiotherapy for ES-NSCLC. A 5% increase in 3-year LC is expected to improve the 3-year CSS and OS rates by 3.8% and 2.8%, respectively.
Results date posted
| 2023 | Year | 08 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Materials and methods: Studies in patients receiving radiotherapy for peripheral ES-NSCLC, mainly staged as T1-2N0M0 were included for a systematic review. Relevant information was collected including, dose fractionation, T stage, median age, 3-year LC, cancer-specific survival (CSS), disease-free survival (DFS), distant metastasis-free survival (DMFS), and OS. Correlations between outcomes and clinical variables were evaluated.
Participant flow
After screening, 101 data points from 87 studies including 13,435 patients were selected for the quantitative synthesis.
Adverse events
Toxicities of grade 3 or higher were low (3.4%).
Outcome measures
Results: After screening, 101 data points from 87 studies including 13,435 patients were selected for the quantitative synthesis. Univariate meta-regression analysis revealed that the coefficients between the 3-year LC and 3-year DFS, DMFS, CSS, and OS were 0.753 (95% confidence interval (CI): 0.307-1.199; p < 0.001), 0.360 (95% CI: 0.128-0.593; p = 0.002), 0.766 (95% CI: 0.489-1.044; p < 0.001), and 0.574 (95% CI: 0.275-0.822; p < 0.001), respectively. Multivariate analysis revealed that the 3-year LC (coefficient, 0.561; 95% CI: 0.254-0.830; p < 0.001) and T1 proportion (coefficient, 0.207; 95% CI: 0.030-0.385; p = 0.012) were significantly associated with the 3-year OS and CSS (coefficient for 3-year LC, 0.720; 95% CI: 0.468-0.972; p < 0.001 and T1 proportion, 0.002; 95% CI: 0.000-0.003; p = 0.012).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | 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 April 1, 2022. The search formula for PubMed is the followings: ((NSCLC OR non-small cell lung cancer OR ((lung OR pulmonary) AND (cancer OR carcinoma OR malignancy OR tumor OR neoplasm OR neoplasms OR carcinomas OR malignancies)) AND ((humans[Filter]) AND (english[Filter]))) AND (SBRT[title] OR SRT[title] OR SABR[title] OR stereotactic[title] AND ((humans[Filter]) AND (english[Filter])))) AND (local control OR local recurrence OR local relapse OR local progression AND ((humans[Filter]) AND (english[Filter]))). 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 local control and overall survival rates will be calculated.
Management information
Registered date
| 2022 | Year | 02 | Month | 14 | Day |
Last modified on
| 2023 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053514
