UMIN-CTR Clinical Trial

Public title

Sublobar resection versus lobectomy for patients with resectable stage I
non-small cell lung cancer with idiopathic pulmonary fibrosis: a phase III study evaluating survival (JCOG1708,SURPRISE trial)

Acronym

Sublobar resection versus lobectomy for patients with resectable stage I
non-small cell lung cancer with idiopathic pulmonary fibrosis: a phase III study evaluating survival (JCOG1708,SURPRISE trial)

Scientific Title

Sublobar resection versus lobectomy for patients with resectable stage I
non-small cell lung cancer with idiopathic pulmonary fibrosis: a phase III study evaluating survival (JCOG1708,SURPRISE trial)

Scientific Title:Acronym

Sublobar resection versus lobectomy for patients with resectable stage I
non-small cell lung cancer with idiopathic pulmonary fibrosis: a phase III study evaluating survival (JCOG1708,SURPRISE trial)

Region

Japan

Condition

Resectable stage I non-small cell lung cancer with idiopathic pulmonary fibrosis

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To confirm the clinical benefit of sublobar resection (wedge resection) for clinical stage I non-small cell lung cancer with idiopathic pulmonary fibrosis (IPF) comparing with lobectomy by randomized phase III trial. The primary objective is to confirm the non-inferiority of sublobar resection to lobectomy in terms of overall survival.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase III

Primary outcomes

Overall survival

Key secondary outcomes

Relapse-free survival, proportion of local recurrence, operation time, blood loss, proportion of acute exacerbation of IPF, postoperative respiratory function at 6 months and 1 year (FVC, FEV1.0 and %DLCO), adverse events, serious adverse events.

Study type

Interventional

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

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

A:lobectomy

Interventions/Control_2

B:Sublobar resection

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

40

years-old

<=

Age-upper limit

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

First registration (preoperative) criteria
1) Imaging findings fulfill all of the following conditions:
i) T1a-2aN0M0 NSCLC suspected
ii) Center of tumor located in the outer third of the lung field
iii) Consolidation/Tumor ratio is > 0.5 if maximum diameter of the tumor is <= 3cm,
iv) Maximum diameter of the tumor < 4 cm
2) No additional tumor nodule from primary tumor
3) All of the following conditions for idiopathic pulmonary fibrosis (IPF) are fulfilled:
i) UIP pattern or possible UIP pattern in the high-resolution CT diagnosed by radiologists
ii) %DLCO < 80 %
iii) Interstitial lung disease (ILD) of unknown etiology
iv) No history of acute exacerbation of IPF
v) No history of systemic steroid for IPF
4) No neuroendocrine tumors
5) Aged 40 to 80 years old
6) ECOG performance status of 0 or 1
7) No following surgical history
i) Ipsilateral thoracotomy
ii) Ipsilateral thoracoscopic resection of lung, esophagus, and mediastinum
iii) Contralateral thoracotomy or thoracoscopic surgery except for wedge resection of the lung
8) No previous treatment of chemotherapy or endocrine therapy in five years
9) No prior radiotherapy to lung, ipsilateral hilum or mediastinum
10) Expected postoperative %FEV1.0 >= 30% and %DLCO >= 30%
11) Sufficient organ functions
12) No ischemic change on ECG
13) Written informed consent

Second registration (intraoperative) criteria
1) Within 14 days of the first registration
2) Histologically confirmed NSCLC
3) Technically possible to perform lobectomy or wedge resection
4) No malignant effusion, dissemination, regional lymph node metastasis, and direct invasion into surrounding organs except for adjacent lobe macroscopically

Key exclusion criteria

1) Synchronous or metachronous (within 5 years) malignancy except cancer with 5-year relative survival rate of 95% or more such as carcinoma in situ, intramucosal tumor, or early stage cancers
2) Active infection requiring systemic therapy.
3) Fever of 38 degree or higher at registration
4) Female during pregnancy, within 28 days of postparturition, or during lactation and male expecting partner's pregnancy
5) Severe psychological disorder
6) Receiving continuous systemic corticosteroid or immunosuppressant treatment
7) Uuncontrollable diabetes mellitus
8) Uncontrollable hypertension
9) Unstable angina, cardiac infarction within the past 6 months
10) Uncontrollable valvular disease or uncontrollable dilated cardiomyopathy or uncontrollable hypertrophic cardiomyopathy

Target sample size

500

Name of lead principal investigator

1st name
Middle name
Last name	Morihito Okada

Organization

Hiroshima University Hospital

Division name

Surgical Oncology

Zip code

Address

1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8511 JAPAN

TEL

082-257-5869

Email

morihito1217@gmail.com

Name of contact person

1st name
Middle name
Last name	(1)Yasuhiro Tsutani (2)Keiju Aokage

Organization

JCOG1708 Coordinating Office

Division name

(1)Surgical Oncology, Hiroshima University Hospital (2)Division of Thoracic Surgery, National Cancer

Zip code

Address

1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8511 JAPAN / 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, J

TEL

(1)082-257-5869.(2)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

National Cancer Center

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

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）
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）
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）
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）
大阪大学医学部（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）
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

2018

Year

05

Month

24

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

Open public recruiting

Date of protocol fixation

2018

Year

03

Month

07

Day

Date of IRB

Anticipated trial start date

2018

Year

05

Month

24

Day

Last follow-up date

2029

Year

11

Month

24

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

05

Month

24

Day

Last modified on

2018

Year

05

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036950