UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021637
Receipt number R000024953
Scientific Title A multicenter and prospective study of multidisciplinary treatment including surgical lung resection for cN0 non-small cell lung cancer patients with synchronous single organ oligometastasis (ILO 1503)
Date of disclosure of the study information 2016/03/29
Last modified on 2018/09/13 10:53:44

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Basic information

Public title

A multicenter and prospective study of multidisciplinary treatment including surgical lung resection for cN0 non-small cell lung cancer patients with synchronous single organ oligometastasis (ILO 1503)

Acronym

Surgical lung resection for non small cell lung cancer with synchronous single organ oligometastasis. (ILO1503)

Scientific Title

A multicenter and prospective study of multidisciplinary treatment including surgical lung resection for cN0 non-small cell lung cancer patients with synchronous single organ oligometastasis (ILO 1503)

Scientific Title:Acronym

Surgical lung resection for non small cell lung cancer with synchronous single organ oligometastasis. (ILO1503)

Region

Japan


Condition

Condition

lung cancer

Classification by specialty

Pneumology Hematology and clinical oncology Chest surgery
Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of multidisciplinary treatment including surgical lung resection for cN0 non-small cell lung cancer patients with synchronous single organ oligometastasis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

2-year overall survival rate

Key secondary outcomes

2-year disease-free survival rate, 5-year overall survival rate, 5-year disease-free survival rate, adverse event, site of relapse


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Do all the treatments of the following 1-3 in any order.
1. Complete resection of primary lung cancer.
2. Any local treatment for synchronous metastasis.
3. Systemic chemotherapy (platinum doublet, 4 courses).

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Preoperative diagnosis as primary non-small cell lung cancer
Clinical stage, T1a-T4, N0M0
Lobectomy, bi-lobectomy or pneumonectomy
Synchronous oligometastasis of single organ with one lesion
(for brain metastases, 5 or less lesions treatable with gamma-knife)
Aged 20-80 years old
ECOG PS0,1
Having operability
Written informed consent

Key exclusion criteria

Active other malingant tumor
HBV, HCV, HIV
Fever up over 38 degree
Having steroid therapy
Bilateral adrenal metastases, bilateral renal metastases, bone metastases
M1a (contralateral lung metastases, malignant pleural effusion, malignant pericardial effusion, pleural dissemination)
Other conditions not suitable for this study

Target sample size

25


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Noriyoshi Sawabata

Organization

Hoshigaoka Medical center

Division name

Thoracic surgery

Zip code


Address

4-8-1 Hoshigaoka, Maikata city, Osaka, Japan

TEL

06-6879-2595

Email

nsawabata@hotmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Tetsukan Woo

Organization

Saiseikai Yokohama City South Hospital

Division name

Thoracic surgery

Zip code


Address

3-2-10 Kounandai, Kounan-ku, Yokohama city, Kanagawa, Japan

TEL

045-832-1111

Homepage URL

http://teikyohaigeka.com/

Email

tetsu.n.u@cotton.ocn.ne.jp


Sponsor or person

Institute

International Lung-clinical-Research Organization

Institute

Department

Personal name



Funding Source

Organization

B 25293301

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


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

星ヶ丘医療センター(大阪府)
山形県立中央病院(山形県)
九州がんセンター(福岡県)
帝京大学(東京都)
浜松医大(静岡県)
順天堂大学(東京都)
済生会横浜市南部病院(神奈川県)
大阪大学(大阪府)


Other administrative information

Date of disclosure of the study information

2016 Year 03 Month 29 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

Open public recruiting

Date of protocol fixation

2016 Year 03 Month 08 Day

Date of IRB


Anticipated trial start date

2016 Year 04 Month 01 Day

Last follow-up date

2024 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

2016 Year 03 Month 27 Day

Last modified on

2018 Year 09 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024953


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name