UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002008
Receipt No. R000002262
Scientific Title A non-randomized confirmatory study of Limited Surgical Resection for Peripheral Early Lung Cancer Defined with Thoracic Thin-section Computed Tomography (JCOG0804/WJOG4507L)
Date of disclosure of the study information 2009/05/26
Last modified on 2016/02/09

* 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 non-randomized confirmatory study of Limited Surgical Resection for Peripheral Early Lung Cancer Defined with Thoracic Thin-section Computed Tomography (JCOG0804/WJOG4507L)
Acronym A non-randomized confirmatory study of Limited Surgical Resection for Peripheral Early Lung Cancer Defined with Thoracic Thin-section Computed Tomography (JCOG0804/WJOG4507L)
Scientific Title A non-randomized confirmatory study of Limited Surgical Resection for Peripheral Early Lung Cancer Defined with Thoracic Thin-section Computed Tomography (JCOG0804/WJOG4507L)
Scientific Title:Acronym A non-randomized confirmatory study of Limited Surgical Resection for Peripheral Early Lung Cancer Defined with Thoracic Thin-section Computed Tomography (JCOG0804/WJOG4507L)
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy and safery of limited resection (wedge resection in general) in patients with small (2 cm or less) peripheral radiological non-invasive lung cancer diagnosed by preoperative thin-section CT images.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Relapse-free survival
Key secondary outcomes overall survival, proportion of local recurrence, postoperative respiratory function, proportion of completion of limited resection, adverse events.

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 Limited pulmonary resection
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
79 years-old >=
Gender Male and Female
Key inclusion criteria 1) Contrast-enhanced thoracic CT fulfills all of the following conditions:
i) lung cancer is suspected,
ii) the number of tumor is three or less,
iii) center of tumor is located in the outer third of the lung field,
iv) no lymph node metastasis.
2) Thin-section CT fulfills both of the following conditions:
i) all tumors are diagnosed as radiological non-invasive cancer,
ii) maximum diameter of any tumor is 2 cm or less.
3) In case pathological or cytological examination is performed preoperatively, pathological diagnosis of the tumor fulfills both of the following conditions:
i) lung adenocarcinoma is suspected (including atypical adenomatous hyperplasia).
ii) all tumors are not diagnosed as being tumor other than adenocarcinoma.
4) Aged 20 to 79 years old.
5) No prior ipsilateral thoracotomy (prior diagnostic thoracoscopy is allowed).
6) No prior chemotherapy or radiation therapy for any malignant diseases (prior hormonal therapy is allowed).
7) Expected postoperative FEV1.0>=800 mL and PaO2>=65 torr.
8) Performance status of 0 or 1.
9) Sufficient organ functions.
10)Written informed consent.
Key exclusion criteria 1) simultaneous or metachronous (within the past 5 years) double cancers.
2) interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema.
3) active bacterial or fungous infection.
4) women during pregnancy or breast-feeding.
5) psychiatric disease.
6) systemic steroids medication.
7) diabetes mellitus treated with insulin or poorly controlled.
8) poorly controlled 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 330

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Tuboi
Organization National Cancer Center Hospital East
Division name Division of Thoracic Surgery
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, JAPAN
TEL 04-7133-1111
Email mtsuboi@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Suzuki
Organization JCOG0804 Study Coordinating Office
Division name Division of Thoracic Surgery, Juntendo University
Zip code
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo, 113-8421, JAPAN
TEL 03-3813-3111
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)
山形県立中央病院(山形県)
日本海総合病院(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)
千葉県がんセンター(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)
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)
金沢大学医学部(石川県)
石川県立中央病院(石川県)
岐阜市民病院(岐阜県)
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)
愛知県がんセンター愛知病院(愛知県)
名古屋大学医学部附属病院(愛知県)
三重大学医学部附属病院(三重県)
滋賀医科大学医学部附属病院(滋賀県)
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)
大阪大学医学部附属病院(大阪府)
大阪市立大学医学部附属病院(大阪府)
国立病院機構大阪医療センター(大阪府)
国立病院機構刀根山病院(大阪府)
市立吹田市民病院(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)
兵庫県立淡路医療センター(兵庫県)
近畿大学医学部奈良病院(奈良県)
倉敷中央病院(岡山県)
岡山大学病院(岡山県)
倉敷中央病院(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)
広島市立広島市民病院(広島県)
広島市立安佐市民病院(広島県)
国立病院機構山口宇部医療センター(山口県)
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)
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)
熊本大学医学部附属病院(熊本県)
大分大学医学部附属病院(大分県)
大分県立病院(大分県)
新別府病院(大分県)

Other administrative information
Date of disclosure of the study information
2009 Year 05 Month 26 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 03 Month 10 Day
Date of IRB
Anticipated trial start date
2009 Year 05 Month 26 Day
Last follow-up date
2025 Year 05 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date
2009 Year 05 Month 26 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=R000002262

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.