UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021637
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute International Lung-clinical-Research Organization
Institute
Department

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
URL(English) https://upload.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


Contact us.