UMIN-CTR Clinical Trial

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

3cm or less lung cancer dominant with ground glass opacity

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2013

Year

09

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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