UMIN-CTR Clinical Trial

Basic information
Public title	Network meta-analysis of adjuvant chemotherapy for NSCLC
Acronym	Adjuvant Chemotherapy for NSCLC
Scientific Title	Network meta-analysis of adjuvant chemotherapy for NSCLC
Scientific Title:Acronym	Adjuvant Chemotherapy for NSCLC
Region	Japan

Condition
Condition	Early-stage non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The primary aim of this study is to assess if Cis-Pemt prolong recurrence-free survival compared to observation using indirect comparison. Besides, comparison of safety profile between Cis-Vnr and Cis-Pemt is secondarily evaluated.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary endpoint is recurrence-free survival assessed by hazard ratio.
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	Patient should have early stage (stage I-IIIa) NSCLC. Sub-pathological type of NSCLC is not questioned. Patients in at least one arm need to be treated with Cis-Vnr or Cis-Pemt. Dose and number of planned cycles of the chemotherapy are not questioned.
Key exclusion criteria	Neoadjuvant chemotherapy or pre-operative chemotherapy is not our concern.
Target sample size

Research contact person
Name of lead principal investigator	1st name Nobuyuki Middle name Last name Horita
Organization	Yokohama City University
Division name	Department of Pulmonology
Zip code	235-0016
Address	3-9, Fukuura, Kanazawa, Yokohama, Japan
TEL	+81457872800
Email	horitano@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Nobuyuki Middle name Last name Horita
Organization	Yokohama City University
Division name	Department of Pulmonology
Zip code	235-0016
Address	3-9, Fukuura, Kanazawa, Yokohama, Japan
TEL	+81457872800
Homepage URL
Email	horitano@yokohama-cu.ac.jp

Sponsor
Institute	Self sponsored
Institute
Department

Funding Source
Organization	None
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	Yokohama City University
Address	3-9, Fikuura, Kanazawa, Yokohama, Japan
Tel	0457872800
Email	nobuyuki_horita@yahoo.co.jp

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
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 12 Month 22 Day
Date of IRB
Anticipated trial start date	2020 Year 12 Month 22 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

The following search formula will be used for PubMed: (pemetrexed or vinorelbine) (non-small cell lung cancer or NSCLC) (adjuvant or neoadjuvant or post-surgery or post-operation) (randomized or randomised or RCT or randomly). Hand search for the NCCN, ASCO, and ESMO guidelines are planned. The frequentist weighted least-squares approach random-model network meta-analysis was performed using R software (Command: netmeta, Package: netmeta) for the primary endpoint.

Management information
Registered date	2020 Year 12 Month 22 Day
Last modified on	2020 Year 12 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048876