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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036796
Receipt No. R000041774
Scientific Title Prospective observational study of activities of daily livings in elderly patients received lung cancer surgery. (JCOG1710A, CANOPUS)
Date of disclosure of the study information 2019/05/20
Last modified on 2019/05/20

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Basic information
Public title Prospective observational study of activities of daily livings in elderly patients received lung cancer surgery. (JCOG1710A, CANOPUS)
Acronym Prospective observational study of activities of daily livings in elderly patients received lung cancer surgery. (JCOG1710A, CANOPUS)
Scientific Title Prospective observational study of activities of daily livings in elderly patients received lung cancer surgery. (JCOG1710A, CANOPUS)
Scientific Title:Acronym Prospective observational study of activities of daily livings in elderly patients received lung cancer surgery. (JCOG1710A, CANOPUS)
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To elucidate how many patients suffer from ADL deterioration, and see whether it is predictable, through evaluation of the post-operative function in elderly non-small cell lung cancer patients (aged over 75 years old, clinical stage 0-III) .
Basic objectives2 Others
Basic objectives -Others To elucidate how many patients suffer from ADL deterioration after surgery
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Proportino of non-worsening of Tokyo Metropolitan Institute of Gerontology Index of Competence Instrumental ADL (TMIG-IADL) at 6 months after lung cancer surgery
Key secondary outcomes TMIG-IADL (changing volume of scale), Japanese EQ-5D-5L QOL scale (changing volume of scale), overall survival, disease free interval, morbidity and mortality

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Tumor suspected of lung cancer on thoracic CT
2) Clinical stage 0-III (UICC-TNM ver. 8)
3) No neuroendocrine tumors
4) Aged over 75 years old
5) Scheduled radical operation within 14 days
6) No induction treatment (chemotherapy, radiotherapy)
7) No previous lung resection
8) No prior radiotherapy fulfilling the following conditions
i) Radiotherapy to ipsilateral hilum or mediastinum
ii) Radiation pneumonitis (>= grade 2)
9) No prior chemotherapy for lung cancer
10) Technically possible to perform all resections at a time
11) Evaluated comprehensive geriatric assessment (TMIG-IALD, G8, CCI, social situation, level of long-care need) within 14 days before registration or scheduled before surgery
12) Possible to communicate using written Japanese
13) Written informed consent
Key exclusion criteria 1) Synchronous or metachronous (within 5 years) malignancy except cancer with 5-year relative survival rate of 95% or more such as carcinoma in situ, intramucosal tumor, or early stage cancers
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Hideo
Middle name
Last name Kunito
Organization Japanese Red Cross Medical Center
Division name Medical Oncology
Zip code 150-8935
Address 4-1-22, Hiroo, Shibuya-ku, Tokyo
TEL 03-3400-1311
Email JCOG_sir@ml.jcog.jp

Public contact
Name of contact person
1st name Hidefumi
Middle name
Last name Takei
Organization JCOG1710A Coordinating Office
Division name Showa University School of medicine Division of Chest Surgery
Zip code 142-8666
Address 1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL 03-3784-8000
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization National Cancer Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Japanese Red Cross Medical Center Institutional Review Board
Address 4-1-22, Hiroo, Shibuya-ku, Tokyo
Tel 03-3400-0104
Email rinri@med.jrc.or.jp

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 北海道大学病院(北海道)
国立病院機構仙台医療センター(宮城県)
東北大学病院(宮城県)
山形県立中央病院(山形県)
茨城県立中央病院・茨城県地域がんセンター(茨城県)
栃木県立がんセンター(栃木県)
群馬県立がんセンター(群馬県)
国立がん研究センター東病院(千葉県)
千葉県がんセンター(千葉県)
千葉大学医学部(千葉県)
国立がん研究センター中央病院(東京都)
杏林大学医学部(東京都)
東京医科大学病院(東京都)
がん・感染症センター都立駒込病院(東京都)
慶應義塾大学病院(東京都)
がん研究会有明病院(東京都)
東京大学医学部(東京都)
順天堂大学医学部附属順天堂医院(東京都)
日本医科大学付属病院(東京都)
聖マリアンナ医科大学(神奈川県)
神奈川県立がんセンター(神奈川県)
横浜市立市民病院(神奈川県)
北里大学医学部(神奈川県)
横浜市立大学附属市民総合医療センター(神奈川県)
新潟県立がんセンター新潟病院(新潟県)
国立病院機構西新潟中央病院(新潟県)
新潟大学医歯学総合病院(新潟県)
金沢大学医学部(石川県)
静岡県立静岡がんセンター(静岡県)
愛知県がんセンター中央病院(愛知県)
名古屋大学医学部(愛知県)
京都大学医学部附属病院(京都府)
大阪大学医学部(大阪府)
大阪市立大学医学部附属病院(大阪府)
大阪国際がんセンター(大阪府)
大阪はびきの医療センター(大阪府)
国立病院機構近畿中央呼吸器センター(大阪府)
大阪市立総合医療センター(大阪府)
神戸大学医学部(兵庫県)
兵庫県立がんセンター(兵庫県)
倉敷中央病院(岡山県)
岡山大学病院(岡山県)
国立病院機構呉医療センター・中国がんセンター(広島県)
広島大学病院(広島県)
国立病院機構四国がんセンター(愛媛県)
国立病院機構九州がんセンター(福岡県)
長崎大学病院(長崎県)
熊本大学医学部(熊本県)
熊本中央病院(熊本県)
大分大学医学部附属病院(大分県)

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 20 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
2019 Year 03 Month 21 Day
Date of IRB
2019 Year 04 Month 26 Day
Anticipated trial start date
2019 Year 05 Month 20 Day
Last follow-up date
2023 Year 05 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To elucidate how many patients suffer from ADL deterioration, and see whether it is predictable, through evaluation of the post-operative function in elderly non-small cell lung cancer patients (aged over 75 years old, clinical stage 0-III) .

Management information
Registered date
2019 Year 05 Month 20 Day
Last modified on
2019 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041774

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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