UMIN-CTR Clinical Trial

Basic information
Public title	A phase II feasibility study of surgical intervention for single station cN2 (UICC 6) non-small cell lung cancer (JNETS 0801)
Acronym	Feasibility study of surgery for single station cN2
Scientific Title	A phase II feasibility study of surgical intervention for single station cN2 (UICC 6) non-small cell lung cancer (JNETS 0801)
Scientific Title:Acronym	Feasibility study of surgery for single station cN2
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	Surgical intervention for clinical N2 non-small cell lung cancer is not accepted as a standard therapy at the present time. Only single station N2 cases involved in all cN2 cases are left to have possible longer survival by surgical interventions. We are now conducting a phase II clinical trial to evaluate a feasibility of surgical treatment in those single station cN2 patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Single station cN2 definition is as follows. Above 10mm and below 20mm in those diameters are evaluated as metastatic nodes by computed tomography, and such positive nodes without spreading more than 2 stations are considered single station cN2. (Regardless of the status of N1 node, PET observations and patho-cytological diagnosis for those nodes) After registration, patients with single station cN2 NSCLC will take lobectomy or pneumonectomy with systematic lymphnode dissection. In some patients, adjuvant chemotherapy after the decision of pathological stating would be recommended. Primary end points of this study are overall survival (3 and 5 years) and disease specific survival (3 and 5 years).
Key secondary outcomes

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	Maneuver
Interventions/Control_1	Surgery Lobectomy or Pneumonectomy Systematic lymphnode dissection (ND2a-2 or more than that is required)
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	Those who have single station metastatic N2 nodes evaluated by computed tomography in patiets with non-small cell lung cancer will be enrolled in this study. (With above 10mm and below 20mm in those shorter diameter are defined as positive nodes.) Acquitision of lung cancer diagnosis is not required before surgical treatment.
Key exclusion criteria	Mediastinal lymphnodes with above 20mm in their shorter diameter. cN2 with over 2 stations. General contraindication for the thoracotomy with low cardio-pulmonary function, liver or renal dysfunction and the others. Age over 76. Extra-nodal invation of cN2 nodes. Distant metastasis. Other malignancies. #1-3(UICC 6) lymphnodes swelling in left side mediastinum. preceding hemotherapy, molecular targetting therapy, thoracic radiotherapy
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takashi Kondo
Organization	Institute for development, aging and cancer (IDAC), Tohoku University
Division name	Department of thoracic surgery
Zip code
Address	4-1 Seiryo-cho, Aoba ward, Sendai, Miyagi Prefecture
TEL	+81-22-717-8526
Email	t-kondo@idac.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Satomi Takahashi
Organization	Miyagi Cancer Center
Division name	Department of thoracic surgery
Zip code
Address	47-1 Nodayama, Medeshima-Shiote, Natori, Miyagi Prefecture
TEL	+81-22-384-3151
Homepage URL
Email	takahashi-sa469@miyagi-pho.jp

Sponsor
Institute	Japan North-East Area Thoracic Oncology Study Group
Institute
Department

Funding Source
Organization	Japan North-East Area Thoracic Oncology Study Group
Organization
Division
Category of Funding Organization	Self funding
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	2014 Year 02 Month 24 Day

Related information
URL releasing protocol	https://www.jtocrr.org/article/S2666-3643(20)30019-9/pdf
Publication of results	Published

Result
URL related to results and publications	https://www.jtocrr.org/article/S2666-3643(20)30019-9/pdf
Number of participants that the trial has enrolled	34
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 02 Month 27 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2008 Year 10 Month 30 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	2014 Year 02 Month 24 Day
Last modified on	2020 Year 07 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015435