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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013247
Receipt No. R000015435
Scientific Title A phase II feasibility study of surgical intervention for single station cN2 (UICC 6) non-small cell lung cancer (JNETS 0801)
Date of disclosure of the study information 2014/02/24
Last modified on 2014/10/14

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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
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 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
2014 Year 10 Month 14 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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