UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011819
Receipt number R000013286
Scientific Title Confirmatory Trial of Segmentectomy for Clinical T1N0 Lung Cancer Dominant with Ground Glass Opacity based on Thin-section Computed Tomography (JCOG1211)
Date of disclosure of the study information 2013/09/20
Last modified on 2015/11/13 17:31:55

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Basic information

Public title

Confirmatory Trial of Segmentectomy for Clinical T1N0 Lung Cancer Dominant with Ground Glass Opacity based on Thin-section Computed Tomography (JCOG1211)

Acronym

Confirmatory Trial of Segmentectomy for Clinical T1N0 Lung Cancer Dominant with Ground Glass Opacity based on Thin-section Computed Tomography (JCOG1211)

Scientific Title

Confirmatory Trial of Segmentectomy for Clinical T1N0 Lung Cancer Dominant with Ground Glass Opacity based on Thin-section Computed Tomography (JCOG1211)

Scientific Title:Acronym

Confirmatory Trial of Segmentectomy for Clinical T1N0 Lung Cancer Dominant with Ground Glass Opacity based on Thin-section Computed Tomography (JCOG1211)

Region

Japan


Condition

Condition

3cm or less lung cancer dominant with ground glass opacity

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To confirm the efficacy of limited resection (lung segmentectomy) in patients with ground glass opacity predominant lung cancer =< 3 cm in diameter based on thin-section computed tomography.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

5-year relapse-free survival

Key secondary outcomes

overall survival, relapse-free survival, proportion of local recurrence, postoperative respiratory function, proportion of segmentectomy completion, proportion of R0 resection completion by segmentectomy, incidence of adverse events, incidence of severe 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

Lung segmentectomy

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 computed tomographic findings fulfill all of the following conditions:
i) lung cancer is suspected (excluding right middle lobe lung cancer).
ii) no lymph node metastasis (cN0).
iii) surgical margin is estimated on preoperative thin-section computed tomography (TSCT) to be more than 2cm or tumor diameter.
2) TSCT findings of the main tumor fulfill any of the following conditions:
i) 2cm< tumor diameter =<3cm and a consolidation/tumor (C/T) ratio =<0.5.
ii) tumor diameter =<2cm and 0.25< C/T ratio =<0.5.
iii) tumor diameter =<2cm, C/T ratio =<0.25 and center of tumor is not located in the outer third of the lung field.
3) The number of additional tumors is 2 or less on TSCT. TSCT findings of the additional tumors fulfill any of the following conditions:
i) tumor diameter =<2cm, C/T ratio =<0.25, and center of tumor is located in the outer third of the lung field.
ii) pure ground glass nodules =<10mm
4) Totally resectable in one stage of one segmentectomy and two or less wedge resections.
5) In case pathological or cytological examination is performed preoperatively, tumor is diagnosed as lung adenocarcinoma pathologically or suspected as lung adenocarcinoma clinically.
6) Aged 20 to 79 years old.
7) No prior affected thoracotomy or thoracoscopic surgery (prior diagnostic thoracoscopy is allowed).
8) No pulmonary resection excluding wedge resection on the unaffected side.
9) No prior chemotherapy or thoracic radiation therapy for any malignant diseases (prior hormonal, neo-adjuvant, or adjuvant therapy is allowed).
10) In case prior thoracic radiation therapy is performed, meet all the following criteria,
i) the hilum or mediastinum of affected side were excluede from radiation field.
ii) No prior radiation pneumonitis of affected side.
11) Expected postoperative FEV1.0>=800 mL and PaO2>=65 torr.
12) Performance status of ECOG 0 or 1.
13) Sufficient organ functions.
14) Written informed consent.

Key exclusion criteria

1) simultaneous or metachronous (within the past 5 years) double cancers other than carcinoma in situ or mucosal carcinoma.
2) active infection requiring treatment.
3) fever higher than 38 degrees C in axillary temperature.
4) women during pregnancy, possibility of pregnancy, or breast-feeding.
5) psychiatric disease.
6) systemic steroids or immunosuppressive 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, attack of angina pectoris within the past 6 months, or multiple cardiac histories.
10) interstitial pneumonitis, pulmonary fibrosis, severe pulmonary emphysema, or multiple pulmonary comorbidities.

Target sample size

390


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenji Suzuki

Organization

Juntendo University Hospital

Division name

Division of Thoracic Surgery

Zip code


Address

2-1-1, Hongo, Bunkyo-ku, Tokyo, 113-8421, JAPAN

TEL

03-3813-3111

Email

kjsuzuki@juntendo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Keiju Aokage

Organization

JCOG1211 Coordinating Office

Division name

Division of Thoracic Surgery, National Cancer Center Hospital East

Zip code


Address

6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, JAPAN

TEL

(+81)04-7133-1111

Homepage URL

http://www.jcog.jp/

Email

JCOG_sir@ml.jcog.jp


Sponsor or person

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

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

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)
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)
新潟県立がんセンター新潟病院(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)
近畿大学医学部(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)
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

2013 Year 09 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

No longer recruiting

Date of protocol fixation

2013 Year 06 Month 05 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 20 Day

Last follow-up date

2027 Year 09 Month 20 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 09 Month 20 Day

Last modified on

2015 Year 11 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013286


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name