UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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)
Title of the study (Brief 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)
Region	Japan

Condition
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

Objectives
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

Assessment
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.

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: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

Eligibility
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

Research contact person
Name of lead principal investigator	Morihito Okada
Organization	Hiroshima University Hospital
Division name	Surgical Oncology
Address	1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8511 JAPAN
TEL	082-257-5869
Email	morihito1217@gmail.com

Public contact
Name of contact person	(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
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

Sponsor
Institute	Japan Clinical Oncology Group (JCOG)
Institute
Department

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)

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） 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）

Other administrative information
Date of disclosure of the study information	2018 Year 05 Month 24 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 03 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 05 Month 24 Day
Last modified on	2018 Year 05 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036950