UMIN-CTR Clinical Trial

Basic information
Public title	prognostic analysis of non-small cell lung cancer patients with pathological stage II-IIIB
Acronym	prognostic analysis of non-small cell lung cancer patients with pathological stage II-IIIB
Scientific Title	prognostic analysis of non-small cell lung cancer patients with pathological stage II-IIIB
Scientific Title:Acronym	prognostic analysis of non-small cell lung cancer patients with pathological stage II-IIIB
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determine the prognostic value of cisplatin unfit in postoperative lung cancer patients with stage II-III pathology requiring cisplatin-based adjuvant chemotherapy
Basic objectives2	Others
Basic objectives -Others	Reasons why standard postoperative adjuvant chemotherapy could not be administered and alternative treatments
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall survival by postoperative adjuvant therapy
Key secondary outcomes

Base
Study type	Observational

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	18 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	patients who underwent surgery for non-small cell lung cancer between 2010 and 2020, patients with pathological stage II-IIIB requiring postoperative adjuvant chemotherapy as standard treatment will be included.
Key exclusion criteria	Non-complete resection cases
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Toyofumi Fengshi Middle name Last name Chen-Yoshikawa
Organization	Nagoya University
Division name	Graduate School of Medicine, Department of Thoracic Surgery
Zip code	4668550
Address	65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, JAPAN
TEL	0527442375
Email	tyoshikawa@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Shota Middle name Last name Nakamura
Organization	Nagoya University
Division name	Graduate School of Medicine, Department of Thoracic Surgery
Zip code	4668550
Address	65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, JAPAN
TEL	0527442375
Homepage URL
Email	shota197065@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

Funding Source
Organization	Nagoya University
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	Nagoya university hospital
Address	65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
Tel	0527442375
Email	shota197065@med.nagoya-u.ac.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	2021 Year 01 Month 05 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	2021 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date	2021 Year 02 Month 01 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	retrospective observational study

Management information
Registered date	2021 Year 01 Month 04 Day
Last modified on	2021 Year 01 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048962

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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