UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042811
Receipt number R000048876
Scientific Title Network meta-analysis of adjuvant chemotherapy for NSCLC
Date of disclosure of the study information 2020/12/22
Last modified on 2020/12/22 11:44:28

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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 or person

Institute

Self sponsored

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048876


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name