UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study of multimodality therapy with introduction chemoradiotherapy before surgery in patients with pathological mediastinal lymph node metastasis (N2 Stage IIIA) non -small cell lung cancer
Acronym	A phase II study of multimodality therapy with introduction chemoradiotherapy before surgery in patients with pathological mediastinal lymph node metastasis (N2 Stage IIIA) non -small cell lung cancer
Scientific Title	A phase II study of multimodality therapy with introduction chemoradiotherapy before surgery in patients with pathological mediastinal lymph node metastasis (N2 Stage IIIA) non -small cell lung cancer
Scientific Title:Acronym	A phase II study of multimodality therapy with introduction chemoradiotherapy before surgery in patients with pathological mediastinal lymph node metastasis (N2 Stage IIIA) non -small cell lung cancer
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy of introduction chemoradiotherapy before surgery in patients with pathological mediastinal lymph node metastasis non-small cell lung cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	2 year recurrence-free survival rate
Key secondary outcomes	Recurrence-free survival time Overall survival time Accomplish treatment rate Response rate of introduction chemoradiotherapy Safety

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Combination treatment with carboplatin (AUC = 5),Day1,29 + Nab-PTX(80mg/m2), Day1, 8, 15, 29, 36, 42. Radiation therapy ; started once a day 1.8 Gy from Day 1, 25 times in total, 45 Gy. Resection more than lobectomy with mediastinal lymph node dissection of ND2a or more. Combination treatment with carboplatin (AUC = 5),Day1,29 + Nab-PTX(80mg/m2), Day1, 8, 15, 29, 36, 42.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Pathologically confirmed stage IIIA, N2, non-small cell lung cancer 2. 20 or older at registration 3. ECOG PS of 0-1 4. Without receiving cytotoxic agents chemotherapy or chest radiotherapy 5.Complete resection can be expected by lobectomy after introduction chemoradiotherapy 6.Postoperative prediction FEV 1.0 <800 ml 7. Adequate organ function Neutrophil cout of more than 1,500/mm3 Hemoglobin cout of more than 9.0g/dL Platelet cout of more than 100,000/mm3 Aspartate transaminase (AST), alanine tran Serum albumin: more than 3.0g/dL saminase(ALT): less than 100IU/L Total bilirubin: less than 2.0mg/dL Serum creatinine of less than 1.5mg/dL SpO2 of more than 94%
Key exclusion criteria	1. History of severe hypersensitivity to taxane group 2. History of severe hypersensitivity to Carboplatin 3. History of severe hypersensitivity to albumin preparation 4. Interstitial lung disease or pulmonary fibrosis 5. Severe infectious disease or severe uncontrolled complication 6. Active malignancy of other organ 7. HBs antigen positive
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Toshihide Yokoyama
Organization	Kurashiki Central Hospital
Division name	Department of respiratory medicine
Zip code
Address	1-1-1 Miwa, Kurashiki, Okayama pref. Japan
TEL	086-422-0210
Email	y14401@kchnet.or.jp

Public contact
Name of contact person	1st name Middle name Last name Toshihide Yokoyama
Organization	Kurashiki Central Hospital
Division name	Department of respiratory medicine
Zip code
Address	1-1-1 Miwa, Kurashiki, Okayama pref. Japan
TEL	086-422-0210
Homepage URL
Email	y14401@kchnet.or.jp

Sponsor
Institute	Department of respiratory medicine, Kurashiki Central Hospital
Institute
Department

Funding Source
Organization	None
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
Address
Tel
Email

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	公益財団法人大原記念倉敷中央医療機構 倉敷中央病院

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 10 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	Terminated
Date of protocol fixation	2017 Year 09 Month 25 Day
Date of IRB	2017 Year 09 Month 21 Day
Anticipated trial start date	2017 Year 10 Month 10 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 10 Month 05 Day
Last modified on	2020 Year 10 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033629