臨床研究等提出・公開システム

Date of registration	Jan. 17, 2019
Last modified on	Sept. 01, 2021
Trial ID	jRCT1051180028

Scientific Title	Induction Chemotherapy and Adjuvant Thoracic Radiation in Resectable Stage N2-3A/3B Non-small Cell Lung Cancer (ICAT in N2-3A/3B NSCLC)
Public Title	Trimodality with Adjuvant Radiation in Stage 3A/3B-N2 Non-small Cell Lung Cancer (ICAT Study)

Completion date	June. 16, 2021
Result actual enrolment	1
Baseline Characteristics	52-year-old female. Non-small cell lung cancer, adenocarcinoma, c-T2aN2M0 stage IIIA
Participant flow	preoperative chemotherapy, completed (n=1) Radical resection, more than lobectomy (n=1) postoperative thoracic radiation 50Gy (n=1) follow up for 2years
Adverse events	No severe adverse event more than grade 3 during protocol treatments
Outcome measures	One patient recruited completed the protocol treatment. The feasibility of therapy was unevaluable.
Brief summary	The feasibility of Trimodality using preoperative chemotherapy, radical resection, and postoperative radiation is still unknown.
Date of posting of results summaries	Sept. 01, 2021
Date of the first journal publication of results	July. 05, 2019
URL hyperlink(s) related to results and publications	https://pubmed.ncbi.nlm.nih.gov/31277165/

Plan to share IPD	No
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCT1051180028

Contact for Scientific Queries	Name	Inoue Masayoshi
	Affiliation	University Hospital, Kyoto Prefectural University of Medicine
	Address	Kajii-cho 465, Kawaramachi-Hirokoji, Kamigyo-Ku ,Kyoto
	Telephone	+81-75-251-5739
	E-mail	mainoue@koto.kpu-m.ac.jp
Contact for Public Queries	Name	Tsunezuka Hiroaki
	Affiliation	University Hospital, Kyoto Prefectural University of Medicine
	Address	Kajii-cho 465, Kawaramachi-Hirokoji, Kamigyo-Ku ,Kyoto
	Telephone	+81-75-251-5392
	E-mail	tsune@koto.kpu-m.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		Dec. 17, 2018
Actual date of first enrollment		Mar. 07, 2019
Target sample size		25
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. c-stage 3A/3B with pathologically diagnosed N2 without chest wall invasion 2.Resectable following induction chemotherapy 3.Normal pulmonary function within 56days before IC 4.No previous chemotherapy or thoracic radiation 5.age 20-75 years at IC 6.ECOG Performance Status0-1 7.Normal bone marrow, liver, and renal function below within 28days before IC 8.Written informed consent was obtained
	Exclusion Criteria	1.Unresectable extra-nodal mediastinal lymph node in CT 2.Contraindication for CBDCA or nab-PTX 3.Past history of severe drug allergy 4.Pulmonary dysfunction 5.Myocardial infarction within 180 days before IC 6.Interstitial pneumonia or pulmonary fibrosis detected in CT 56days before IC 7.Medication with PSL more than 10mg/day 90days before IC 8.Clinically relevant heart disease 9.Clinically relevant psychological disorder 10.Uncontrollable DM 11.Clinically relevant infection disease 12.Other clinically relevant comorbidity 13.Active double cancer 14.Pregnant, lactating, possibly pregnant 15.Inappropriate by investigator
	Age Minimum	20age old over
	Age Maximum	75age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Non-small cell lung cancer
Intervention(s)		Chemotherapy, surgery, radiation
Health Condition(s) Keyword		Lung Cancer, Trimodality
Primary Outcome(s)		Treatment completion
Secondary Outcome(s)		Response of induction chemotherapy, treatment related adverse events, progression free survival, Overall survival

Source of Monetary Support	Uehara Memorial Foundation
Secondary Sponsor	Not applicable

Name of Certified Review Board	Kyoto Prefectural University of Medicine, Clinical Research Review Board
Address	Kajii-cho 465, Kawaramachi-Hirokoji, Kamigyo-Ku ,Kyoto, Kyoto
Telephone	+81-75-251-5337
E-Mail	rinri@koto.kpu-m.ac.jp
Approval Status	Approval
Date of approval	Feb. 19, 2019

Secondary ID(s)	UMIN000025010
Issuing Authority	University Hospital Medical Information Network (UMIN)

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	Sept. 01, 2021	(this page)	Changes
4	Jan. 25, 2021	Detail	Changes
3	July. 15, 2020	Detail	Changes
2	Mar. 08, 2019	Detail	Changes
1	Jan. 17, 2019	Detail

List of change history