UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040818
Receipt number R000045639
Scientific Title Prospective Evaluation of Watchful Waiting for Early-Stage Lung Cancer with Ground-Glass Opacity: A Single-Arm Confirmatory Multicenter Study
Date of disclosure of the study information 2020/06/18
Last modified on 2020/06/18 11:09:05

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Basic information

Public title

Prospective Evaluation of Watchful Waiting for Early-Stage Lung Cancer with Ground-Glass Opacity: A Single-Arm Confirmatory Multicenter Study
(JCOG1906, EVERGREEN)

Acronym

Prospective Evaluation of Watchful Waiting for Early-Stage Lung Cancer with Ground-Glass Opacity: A Single-Arm Confirmatory Multicenter Study
(JCOG1906, EVERGREEN)

Scientific Title

Prospective Evaluation of Watchful Waiting for Early-Stage Lung Cancer with Ground-Glass Opacity: A Single-Arm Confirmatory Multicenter Study

Scientific Title:Acronym

Prospective Evaluation of Watchful Waiting for Early-Stage Lung Cancer with Ground-Glass Opacity: A Single-Arm Confirmatory Multicenter Study

Region

Japan


Condition

Condition

Clinical stage IA non-small cell lung cancer, radiologically noninvasive lung cancer

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this single-arm study is to confirm the efficacy and safety of watchful waiting for patients with radiologically noninvasive lung cancer based on thin-section computed tomography (CT).

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

10-year overall survival

Key secondary outcomes

5-year overall survival, 5- and 10-year operation-free survival, 5- and 10-year extensive lung resection rate, 5- and 10-year unresectable progression rate, 5- and 10-year lung cancer specific survival, 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

A: Watchful waiting until the lesion meets the resection criteria (follow-up with chest thin-section CT every 6 months for the first 3 years and every year for the next 10 years after registration)

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

Inclusion criteria at primary registration
(1)Fulfills all the following conditions on chest thin-section CT
(i)cN0M0 NSCLC is suspected
(ii)Within 3 lesions (Bilateral lesions are allowed)
(iii)Maximum diameter of the tumor <= 2 cm and C/T ratio <= 0.25
(iv)Pure-GGN with maximum diameter of the tumor <= 1 cm is ineligible
(v) Not adjacent to the pleura
(vi)No pleural indentation
(vii) No chest thin-section CT has been performed prior to 168 days (24 weeks) of registration
(2)Aged 20 to 79 years old
(3)PS of 0 to 1
(4)No prior medical treatment for any type of tumor (hormone therapy and Pre- and postoperative adjuvant chemotherapy are allowed) and no prior radiation therapy on the lungs, hilum or mediastinum
(5)Fulfills both of the following conditions
(i)Predicted postoperative FEV1 >= 800ml
(ii)SpO2 >= 93%
(6)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
(7)Written informed consent

Secondary registration criteria
(1)Within 196 days of the primary registration
(2) No tumor regression or enlargement between the initial and second thin-section chest CT {The second CT is taken between 84 days (12 weeks) and 140 days (20 weeks) after the date of the initial CT}
(3) Within 56 days (8 weeks) of the second CT

Key exclusion criteria

(1)History of synchronous or metachronous (within 5 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
(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

720


Research contact person

Name of lead principal investigator

1st name Keiju
Middle name
Last name Aokage

Organization

National Cancer Center Hospital East

Division name

Division of Thoracic Surgery

Zip code

277-8577

Address

6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan.

TEL

04-7133-1111

Email

JCOG_sir@ml.jcog.jp


Public contact

Name of contact person

1st name Tomohiro
Middle name
Last name Miyoshi

Organization

JCOG1906 Coordinating Office

Division name

Division of Thoracic Surgery, National Cancer Center Hospital East

Zip code

277-8577

Address

6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan.

TEL

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

National Cancer Center

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



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)
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)
慶應義塾大学病院(東京都)
がん研究会有明病院(東京都)
東京大学医学部(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)
北里大学医学部(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)
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 06 Month 18 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 03 Month 21 Day

Date of IRB

2020 Year 05 Month 29 Day

Anticipated trial start date

2020 Year 06 Month 18 Day

Last follow-up date

2036 Year 06 Month 18 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 06 Month 18 Day

Last modified on

2020 Year 06 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045639


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name