UMIN-CTR Clinical Trial

Basic information
Public title	Induction Chemotherapy and Adjuvant Thoracic Radiation in Resectable Stage N2-3A/3B Non-small Cell Lung Cancer (ICAT study)
Acronym	Trimodality with Adjuvant Radiation in Stage N2-3A/3B Non-small Cell Lung Cancer
Scientific Title	Induction Chemotherapy and Adjuvant Thoracic Radiation in Resectable Stage N2-3A/3B Non-small Cell Lung Cancer (ICAT study)
Scientific Title:Acronym	Trimodality with Adjuvant Radiation in Stage N2-3A/3B Non-small Cell Lung Cancer
Region	Japan

Condition
Condition	Resectable Stage 3A-N2 Non-small Cell Lung Cancer
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the feasibility of trimodality treatment with induction chemotherapy, radical surgery, and adjuvant radiation in stage 3A-N2 non-small cell lung cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	feasibility
Key secondary outcomes	response rate of induction chemotherapy, safety, progression free survival

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	Trimodality treatment with 3 course of induction chemotherapy with Carboplatin AUC5 and nab-Paclitaxel 100mg/m2, radical surgery more than lobectomy, adjuvant radiation 50Gy
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	20 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	1.Stage 3A non-small-cell lung cancer (NSCLC) with mediastinal lymph node metastasis (N2) confirmed pathologically without chest wall invasion 2.R0 radical surgery is expected after induction chemotherapy 3.Normal pulmonary function (%VC > 80%, FEV1% > 70%) within 56 days prior to consent 4.Chemotherapy-naive and radiotherapy-naive 5.20 - 75 years of age at enrollment 6.ECOG Performance Status 0-1 7.The latest clinical laboratory test within 28 days prior to enrollment meets the following all standard Leukocyte count > 3,000/mm3 Hemoglobin > 10.0g/dl Platelet > 100,000/mm3 Total bilirubin < 1.5mg/dl Serum albumin > 3.0g/dl AST/ALT < 100 IU Creatinine < 1.2mg/dl SpO2 > 95% 8.Patients providing the written informed consent for this trial
Key exclusion criteria	1.Evident unresectable extranodal lymph node involvement in CT scanning 2.Contraindication to either carboplatin or nab-paclitaxel 3.History of severe drug hypersensitivity 4.Impaired pulmonary function 5.Myocardial infarction within 6 months (180 days) prior to consent 6.Interstitial pneumonia, pulmonary fibrosis suspected or diagnosed within 56 days prior to consent 7.Administration of prednisolone > 10mg/day within 90 days prior to consent 8.Clinically severe heart diseases 9.Clinically severe psychiatric diseases 10.Uncontrollable diabetes mellitus 11.Clinically active infection 12.Any other severe complication 13.Active double malignancies 14.Pregnant, lactating or possibly pregnant 15.Any other unsuitable reasons judged by attending investigators
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Masayoshi Middle name Last name Inoue
Organization	Kyoto Prefectural University of Medicine
Division name	Division of Thoracic Surgery, Department of Surgery
Zip code	6028566
Address	Kajii-cho 465, Kawaramachi-Hirokoji, Kamigyo-Ku ,Kyoto
TEL	+81752515739
Email	mainoue@koto.kpu-m.ac.jp

Public contact
Name of contact person	1st name Hiroaki Middle name Last name Tsunezuka
Organization	Kyoto Prefectural University of Medicine
Division name	Division of Thoracic Surgery, Department of Surgery
Zip code	6028566
Address	Kajii-cho 465, Kawaramachi-Hirokoji, Kamigyo-Ku ,Kyoto
TEL	075-251-5739
Homepage URL
Email	tsune@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Kyoto Prefectural University of Medicine Division of Thoracic Surgery, Department of Surgery
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kyoto Prefectural University of Medicine The Center for Quality Assurance in Research and Development
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyoto Prefectural University of Medicine, IRB
Address	Kajii-cho 465, Kawaramachi-Hirokoji, Kamigyo-Ku ,Kyoto
Tel	0752515337
Email	rinri@koto.kpu-m.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	2016 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	1
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	Completed
Date of protocol fixation	2016 Year 12 Month 15 Day
Date of IRB	2017 Year 10 Month 13 Day
Anticipated trial start date	2018 Year 11 Month 01 Day
Last follow-up date	2021 Year 06 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 11 Month 27 Day
Last modified on	2021 Year 09 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028775