UMIN-CTR Clinical Trial

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

Non-small cell lung cancer

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

YES

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Japan North-East Area Thoracic Oncology Study Group

Institute

Department

Personal name

Organization

Japan North-East Area Thoracic Oncology Study Group

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

02

Month

24

Day

URL releasing protocol

https://www.jtocrr.org/article/S2666-3643(20)30019-9/pdf

Publication of results

Published

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

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 related information

Registered date

2014

Year

02

Month

24

Day

Last modified on

2020

Year

07

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015435