UMIN-CTR Clinical Trial

Basic information
Public title	A prospective randomized control trial comparing systematic and selective mediastinal lymph node dissection in elderly non-small cell lung cancer patients.
Acronym	A prospective RCT comparing systematic and selective mediastinal lymph node dissection in elderly NSCLC patients.
Scientific Title	A prospective randomized control trial comparing systematic and selective mediastinal lymph node dissection in elderly non-small cell lung cancer patients.
Scientific Title:Acronym	A prospective RCT comparing systematic and selective mediastinal lymph node dissection in elderly NSCLC patients.
Region	Japan

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

Objectives
Narrative objectives1	To demonstrate the superiority of selective lymph node dissection comparing with systematic lymph node dissection about postoperative complication rate in elderly patients with non-small cell lung cancer(earlier than cT2N1M0).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	The rate of complications in the early postoperative period
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Systematic Lymph node Dissection
Interventions/Control_2	Selective Lymph node Dissection
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	75 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	First stage registration 1)Contrast-enhanced CT, positron emission tomography-CT (or bone scintigraphy) and enhanced brain MRI findings fulfill all of the following conditions. i)resectable lung tumors. ii)no more than cT2a and without inter-lobe PL3. iii)no metastasis in mediastinal lymph nodes iv)non-small cell lung carcinoma is diagnosed or suspected. Neither Carcinoid nor large-cell neuroendocrine carcinoma. v)no distant metastasis. 2)Aged 75 or older. 3)No past history of ipsilateral thoracotomy. 4)No surgery, chemotherapy or radiation therapy for any malignant diseases in the past two years. 5)Lobectomy and systematic lymph node dissection are acceptable with following conditions. i) Predicted FEV1.0 <= 800mL ii) PaO2 >= 65 torr(room air) or SaO2 >= 94% (room air) 6)Performance Status(ECOG) is 0 or 1. 7)Hugh-Jones classification is I, II or III. 8)Checked about heart disease. 9)Checked about COPD. 10)Blood examinations fulfill following conditions i) WBC>=3,000 /mm3 ii) Hb>=8.0 g/dL iii) Plt>=10x104 /mm3 iv) AST<=100 U/L v) ALT<=100 U/L vi) T-bil<=2.0 mg/dL vii) Cre<=1.5 mg/dL 11) Written informed consent. Second stage registration Preoperative criteria 1)Sufficient organ functions. 2)Preoperative body temperature is 38C or less. Intraoperative criteria 1)The date of surgery (second registration) is within 42 days of the first registration. 2)Non-small cell lung carcinoma is diagnosed. Neither carcinoid nor large-cell neuroendocrine carcinoma. 3)Neither malignant pleural effusion nor pleural dissemination. 4)No inter-lobe PL3. 5)Pleural lavage cytology is not imperative and that result dose not affect the eligibility. 6)Completion of lobectomy and selective lymph node dissection. Metastasis is not diagnosed with frozen examination in the representative lymph nodes, including cN1, which are defined in the protocol. 7)No mediastinoscopy. 8)Latissimus dorsi and serratus anterior muscles are not cut completely. 9)Single lobectomy without angioplasty and bronchoplasty.
Key exclusion criteria	1)Simultaneous or metachronous (within the past 2 years) double lung cancers. 2)Past history of #7 lymph node dissection for contralateral lung cancer resection. 3)Preoperative mediastinoscopy. 4)Interstitial pneumonitis. 5)Active bacterial or fungous infection. 6)Psychiatric disease. 7)Systemic steroids medication. 8)Uncontrollable diabetes mellitus. 9)Uncontrollable hypertension. 10)Past history of severe heart disease, heart failure, myocardial infarction within the past 6 months or attack of angina pectoris within the past 6 months. 11)The attending doctor does not identify as eligible clinically.
Target sample size	530

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shinichiro Miyoshi
Organization	Okayama University Hospital
Division name	Department of Thoracic Surgery
Zip code
Address	2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL	086-235-7265
Email	surgery2@md.okayama-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Junichi Soh
Organization	Okayama University Hospital
Division name	Department of Thoracic Surgery
Zip code
Address	2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL	086-235-7265
Homepage URL
Email	surgery2@md.okayama-u.ac.jp

Sponsor
Institute	Okayama University Thoracic Surgery Study Group
Institute
Department

Funding Source
Organization	Donation for research
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

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 07 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	2015 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date	2015 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 05 Month 03 Day
Last modified on	2019 Year 08 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019491