UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040089
Receipt number R000045327
Scientific Title Anatomical segmentectomy versus wedge resection in high-risk operable patients with clinical stage IA non-small cell lung cancer: A randomized phase III trial.
Date of disclosure of the study information 2020/04/07
Last modified on 2020/04/07 11:44:13

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Basic information

Public title

Anatomical segmentectomy versus wedge
resection in high-risk operable patients with
clinical stage IA non-small cell lung cancer:
A randomized phase III trial.
(JCOG1909, ANSWER)

Acronym

Anatomical segmentectomy versus wedge
resection in high-risk operable patients with
clinical stage IA non-small cell lung cancer:
A randomized phase III trial.
(JCOG1909, ANSWER)

Scientific Title

Anatomical segmentectomy versus wedge
resection in high-risk operable patients with
clinical stage IA non-small cell lung cancer:
A randomized phase III trial.

Scientific Title:Acronym

Anatomical segmentectomy versus wedge
resection in high-risk operable patients with
clinical stage IA non-small cell lung cancer:
A randomized phase III trial.

Region

Japan


Condition

Condition

clinical stage IA non-small cell lung cancer

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this randomized trial is to confirm the superiority of anatomical segmentectomy to wedge resection in overall survival for high-risk operable patients with clinical stage IA non-small cell lung cancer.

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

Adverse events, postoperative respiratory function, relapse-free survival, proportion of local recurrences, operation time, blood loss.


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:Wedge resection

Interventions/Control_2

B:Anatomical 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


Not applicable

Gender

Male and Female

Key inclusion criteria

Inclusion criteria at primary registration
(1)Fulfills all the following conditions on imaging studies
(i)cT1N0M0 NSCLC is suspected
(ii)Center of the tumor is located in the outer third of the lung field.
(iii)Maximum diameter of the tumor <= 3 cm
(iv)C/T ratio is > 0.5
(2)No satellite tumors
(3)Fulfills the definition for high-risk in lung lobectomy (fulfills more than one major criterion or more than 2 minor criteria)
Major criteria
(a)%FEV1 <= 50%
(b)%DLCO <= 50%
Minor criteria
(c)Aged 75 years or older
(d)%FEV1 > 50% and %FEV1 <= 60%
(e)%DLCO > 50% and %DLCO <= 60%
(f)Pulmonary hypertension
(g)Left ventricular dysfunction
(h)PaO2 <= 55 mmHg or SpO2 <= 88%
(i)PaCO2 > 45 mmHg
(j)Modified Medical Research Council Dyspnea Scale grade 3 or higher
(4)Negative for neuroendocrine tumor if cytology tests are performed
(5)Aged 20 years or older
(6)PS of 0 to 1
(7)No prior medical treatment for any type of tumor in the past 2 years (hormone therapy is allowed)
(8)No prior radiation therapy on the lungs, hilum or mediastinum
(9)Fulfills both of the following conditions
(i)Predicted postoperative %FEV1 >= 30%
(ii)Predicted postoperative %DLCO >= 30%
(10)Sufficient organ function. (All test results must be obtained within 28 days before enrollment.)
(i)White blood cell count >= 3,000/mm3
(ii)Hemoglobin >= 8.0 g/dL
(iii)Platelet count >= 100,000/mm3
(iv)Total bilirubin <= 2.0 mg/dL
(v)AST <= 100 U/L
(vi)ALT <= 100 U/L
(vii)Creatinine <= 1.5 mg/dL
(11)No sign of ischemia on latest ECG.
(12)Written informed consent.

Secondary registration (intraoperative) criteria
(1)Within 14 days of the primary registration
(2)Histological confirmation of NSCLC before surgery or during surgery by diagnostic wedge resection or needle biopsy.
(3)Technically possible to perform wedge resection and anatomical segmentectomy.
(4)No signs of malignant effusion, dissemination, regional lymph node metastasis, and direct invasion into surrounding organs except for adjacent lung regions.

Key exclusion criteria

(1) History of synchronous or metachronous (within 2 years) malignancies with 5-year relative survivals of less than 95% at the time of diagnosis.)
(2) Active infection requiring systemic therapy.
(3) Fever of higher than 38.0 degrees Celsius at the time of enrollment.
(4) Pregnant, possibly pregnant, within 28 days after delivery, breastfeeding female or males expecting conception of their child.
(5) Psychiatric illnesses or symptoms affecting daily lives.
(6) Systemic administration of steroids or immunosuppressive agents either orally or intravenously.
(7) Uncontrollable diabetes (HbA1c > 8%).
(8) Uncontrollable hypertension.
(9) Unstable angina (diagnosis or worsening of chest pain within 3 weeks) or history of myocardial infarction within 6 months prior to enrollment.
(10) Uncontrollable heart valve disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.
(11) Diagnoses of interstitial pneumonia, pulmonary fibrosis, or both, on chest CT.

Target sample size

370


Research contact person

Name of lead principal investigator

1st name Kenji
Middle name
Last name Suzuki

Organization

Juntendo University

Division name

Division of Thoracic Surgery

Zip code

113-8421

Address

2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan.

TEL

03-3813-3111

Email

JCOG_sir@ml.jcog.jp


Public contact

Name of contact person

1st name Yasuhiro
Middle name
Last name Tsutani

Organization

JCOG1909 Coordinating Office

Division name

Surgical Oncology, Hiroshima University Hospital

Zip code

734-8551

Address

1-2-3 Kasumi, Minami-ku, Hiroshima, Japan

TEL

082-257-5869

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

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

National Cancer Center Institutional Review Board

Address

5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan

Tel

03-3542-2511

Email

NCC_IRBoffice@ml.res.ncc.go.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

国立病院機構仙台医療センター(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)
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)
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)
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)
岐阜大学医学部(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(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)
産業医科大学(福岡県)
九州大学病院(福岡県)
長崎大学病院(長崎県)
熊本大学病院(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

2020 Year 04 Month 07 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

2020 Year 02 Month 04 Day

Date of IRB

2020 Year 03 Month 30 Day

Anticipated trial start date

2020 Year 04 Month 07 Day

Last follow-up date

2031 Year 04 Month 07 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 04 Month 07 Day

Last modified on

2020 Year 04 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045327


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name