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 | 2024/04/02 14:00:13 |
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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
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/
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
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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 14 | Day |
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
| 2024 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024953
