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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002317
Receipt No. R000002300
Scientific Title A phase III randomised trial of lobectomy versus limited resection (segmentectomy) for small (2 cm or less) peripheral non-small cell lung cancer (JCOG0802/WJOG4607L)
Date of disclosure of the study information 2009/08/10
Last modified on 2016/02/09

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Basic information
Public title A phase III randomised trial of lobectomy versus limited resection (segmentectomy) for small (2 cm or less) peripheral non-small cell lung cancer (JCOG0802/WJOG4607L)
Acronym A phase III randomised trial of lobectomy versus limited resection (segmentectomy) for small (2 cm or less) peripheral non-small cell lung cancer (JCOG0802/WJOG4607L)
Scientific Title A phase III randomised trial of lobectomy versus limited resection (segmentectomy) for small (2 cm or less) peripheral non-small cell lung cancer (JCOG0802/WJOG4607L)
Scientific Title:Acronym A phase III randomised trial of lobectomy versus limited resection (segmentectomy) for small (2 cm or less) peripheral non-small cell lung cancer (JCOG0802/WJOG4607L)
Region
Japan

Condition
Condition small (2 cm or less) peripheral non-small cell lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the non-inferiority of overall survival of segmentectomy for lobectomy in patients with small peripheral non-small cell lung cancer (2 cm or less, the proportion of maximum diameter of the tumor itself to consolidation >0.5) .
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes overall survival
Key secondary outcomes postoperative respiratory function, relapse-free survival, proportion of local recurrence, adverse events, proportion of completion of segmentectomy, days of hospitalization, duration of chest tube placement, operation time, blood loss, number of used auto-sutures.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 A: Pulmonary lobectomy
Interventions/Control_2 B: Pulmonary segmentectomy
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
85 years-old >=
Gender Male and Female
Key inclusion criteria Preoperative criteria,
1) Contrast-enhanced thoracic CT fulfills all of the following conditions:
i) single tumor,
ii) non-small cell lung cancer is suspected,
iii) Center of tumor is located in the outer third of the lung field,
iv) the tumor is not located at middle lobe,
v) no lymph node metastasis.
2) Thin-section CT fulfills both of the following conditions:
i) maximum diameter of the tumor is 2 cm or less,
ii) the proportion of maximum diameter of the tumor itself to consolidation is more than 0.5. 3) Aged 20 to 79 years old.
4) No prior ipsilateral thoracotomy (prior diagnostic thoracoscopy is allowed).
5) No prior chemotherapy or radiation therapy for any malignant diseases.
6) Expected postoperative FEV1.0>=800 mL and PaO2>=65 torr.
7) Performance status of 0 or 1.
8) Sufficient organ functions.
9) preoperative body temperature is 38C or less
10)Written informed consent.

Intraoperative criteria,
1) the date of surgery (second registration) is within 28 days of the first registration,
2) histologically confirmed either adenocarcinoma, adenosquamous carcinoma,
large cell carcinoma, or non-small cell lung cancer (detailed category unknown),
3) neither malignant pleural effusion nor pleural dissemination,
4) no lymph node metastasis
5) technically possible to perform any of the following procedures: lobectomy, segmentectomy,
and nodal dissection.
Key exclusion criteria 1) Active bacterial or fungous infection.
2) Simultaneous or metachronous (within the past 5 years) double cancers.
3) Women during pregnancy or breast-feeding.
4) Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema.
5) Psychosis.
6) Systemic steroids medication.
7) Uncontrollable diabetes mellitus.
8) Uncontrollable hypertension.
9) History of severe heart disease, heart failure, myocardial infarction within the past 6 months or attack of angina pectoris within the past 6 months.
Target sample size 1100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisao Asamura
Organization Keio University School of Medicine
Division name Division of Thoracic Surgery
Zip code
Address Shinanomachi 35, Shinjuku-ku, Tokyo 160-8582, JAPAN
TEL 03-5363-3805
Email hasamura@a3.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Tsuboi / Hisashi Saji
Organization JCOG0802 Study Coordinating Office
Division name Division of Thoracic Surgery, Kanagawa Cancer Center/St. Marianna University School of Medicine Hosp
Zip code
Address 1-1-2, Nakao, Asahi-ku, Yokohama, 241-0815, JAPAN / 2-16-1, Sugao, Miyamae-ku, Kawasaki, 216-8511
TEL (045)-391-5761(044)-977-8111
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group(JCOG)
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor West Japan Oncology Group (WJOG)
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 旭川医科大学病院(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)
山形大学医学部附属病院(山形県)
公立大学法人 福島県立医科大学附属病院(福島県)
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)
千葉県立がんセンター(千葉県)
国立がん研究センター東病院(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)
順天堂大学医学部附属順天堂医院(東京都)
聖マリアンナ医科大学(神奈川県)
神奈川県立病院機構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)
横浜市立大学附属市民総合医療センター(神奈川県)
神奈川県立循環器呼吸器病センター(神奈川県)
相模原協同病院(神奈川県)
北里大学病院(神奈川県)
新潟県立がんセンター新潟病院(新潟県)
西新潟中央病院(新潟県)
金沢大学医学部(石川県)
石川県立中央病院(石川県)
昭和伊南総合病院(長野県)
信州大学医学部附属病院(長野県)
岐阜市民病院(岐阜県)
岐阜大学医学部附属病院(岐阜県)
静岡県立静岡がんセンター(静岡県)
浜松医科大学医学部附属病院(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)
三重大学医学部附属病院(三重県)
京都大学医学部附属病院(京都府)
大阪大学医学部(大阪府)
大阪府立病院機構大阪府立成人病センター(大阪府)
大阪府立病院機構大阪府立呼吸器・アレルギー医療センター(大阪府)
国立病院機構近畿中央胸部疾患センター(大阪府)
大阪市立総合医療センター(大阪府)
刀根山病院(大阪府)
市立吹田市民病院(大阪府)
大阪市立大学医学部附属病院(大阪府)
兵庫県立がんセンター(兵庫県)
神戸市立医療センター中央市民病院(兵庫県)
兵庫県立淡路病院(兵庫県)
近畿大学医学部奈良病院(奈良県)
鳥取大学医学部附属病院(鳥取県)
倉敷中央病院(岡山県)
岡山大学病院(岡山県)
川崎医科大学附属病院(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)
広島市立安佐市民病院(広島県)
広島市立広島市民病院(広島県)
済生会広島病院(広島県)
山口宇部医療センター(山口県)
山口大学医学部附属病院(山口県)
国立病院機構四国がんセンター(愛媛県)
高知医療センター(高知県)
国立病院機構九州がんセンター(福岡県)
社会医療法人 製鉄記念八幡病院(福岡県)
九州大学病院(福岡県)
長崎大学病院(長崎県)
日本赤十字社 長崎原爆病院(長崎県)
熊本大学医学部(熊本県)
熊本中央病院(熊本県)
熊本地域医療センター(熊本県)
大分大学医学部附属病院(大分県)
新別府病院(大分県)
大分県立病院(大分県)

Other administrative information
Date of disclosure of the study information
2009 Year 08 Month 10 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 No longer recruiting
Date of protocol fixation
2009 Year 01 Month 09 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 10 Day
Last follow-up date
2020 Year 08 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is conducted as intergroup study of Japan Clinical Oncology Group(JCOG) and West Japan Oncology Group(WJOG) .

Management information
Registered date
2009 Year 08 Month 10 Day
Last modified on
2016 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002300

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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