UMIN-CTR Clinical Trial

Public title

A randomized phase III trial of lobe-specific vs. systematic nodal dissection for c-stage I/II non-small cell lung cancer (JCOG1413, L-SPEC trial)

Acronym

A randomized phase III trial of lobe-specific vs. systematic nodal dissection for c-stage I/II non-small cell lung cancer (JCOG1413, L-SPEC trial)

Scientific Title

A randomized phase III trial of lobe-specific vs. systematic nodal dissection for c-stage I/II non-small cell lung cancer (JCOG1413, L-SPEC trial)

Scientific Title:Acronym

A randomized phase III trial of lobe-specific vs. systematic nodal dissection for c-stage I/II non-small cell lung cancer (JCOG1413, L-SPEC trial)

Region

Japan

Condition

Clinical stage I/II non-small cell lung cancer except for the following;
i) Maximum diameter of the tumor including GGA <= 2 cm and cN0
ii) GGA-dominant (Consolidation/Tumor ratio <= 0.5) and maximum diameter of the tumor is >2 cm and <= 3 cm and cN0
iii) cT3N0 with direct invasion to chest wall (including superior sulcus tumor), phrenic nerve, and pericardium
iv) cN1 with extranodal invasion (defect image in bronchial and vascular walls)

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

<Upper and lower lobe tumors>
To confirm the clinical benefit of lobe-specific nodal dissection for clinical stage I/II non-small cell lung cancer comparing with systematic nodal dissection by randomized phase III trial. The primary objective is to confirm the non-inferiority of lobectomy plus lobe-specific nodal dissection to lobectomy plus systematic nodal dissection in terms of overall survival.

<Middle lobe tumors>
To clarify whether overall survival of the clinical stage I/II non-small cell lung cancer patients who undergo right middle lobectomy plus systematic nodal dissection is different from that of the patients who undergo upper and lower lobectomy plus systematic nodal dissection.

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, proportion of local lymph node recurrence, operation time, blood loss, length of hospitalization, duration of chest tube placement, 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

3

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

A: Upper or lower lobectomy plus systematic nodal dissection

Interventions/Control_2

B: Upper or lower lobectomy plus lobe-specific nodal dissection

Interventions/Control_3

C: Middle lobectomy plus systematic nodal dissection

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

First registration (preoperative) criteria
1) Tumor suspected of lung cancer on thoracic CT
2) No additional tumor nodule in different lobe from primary tumor
3) Clinical stage I/II except for the following conditions (UICC-TNM ver. 8)
i) Maximum diameter of the tumor including GGA is <= 2cm and cN0
ii) GGA-dominant (Consolidation/Tumor ratio<= 0.5) and maximum diameter of the tumor is > 2-3cm and cN0
iii) cT3N0 with direct invasion to chest wall, phrenic nerve, and pericardium
iv) cN1 with extranodal invasion (defect image in bronchial and vascular walls)
4) No neuroendocrine tumors
5) Aged 20 to 79 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 (except for thoracoscopic resection of bullae)
iii) Contralateral thoracotomy or thoracoscopic surgery except for wedge resection of the lung
8) No prior chemotherapy (prior postoperative adjuvant chemotherapy and hormone therapy are allowed)
9) No prior radiotherapy fulfilling the following condition
i) Radiotherapy to ipsilateral hilum and mediastinum
ii) Ipsilateral radiation pneumonitis (>= grade 2)
10) Expected postoperative FEV1.0>=800 mL and SpO2>=93% (room air).
11) Technically possible to perform all resections (lobectomy, lobectomy plus one segmentectomy, or lobectomy plus <=2 wedge resections) at a time
12) Sufficient organ functions
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 and lymph node dissection
4) No malignant effusion, dissemination, hilar (#10, #11) / mediastinal node metastasis, and direct invasion into surrounding organs except for adjacent lobe macroscopically
5) Negative hilar (#10, #11) node on frozen section for cN1 tumor suspected of hilar (#10, #11) node metastasis preoperatively

Key exclusion criteria

1) Synchronous double/multiple cancer or metachronous double/multiple cancer with disease-free period of 5 years or shorter, except for following;; prostate cancer with clinical stage I and completely resected following cancers; gastric cancer (adenocarcinoma) with stage 0-I, colon cancer (adenocarcinoma) with stage 0-I, esophageal cancer (squamous cell carcinoma, adenosquamous carcinoma, basaloid carcinoma) with stage 0, breast cancer (noninvasive ductal carcinoma and noninvasive lobular carcinoma) with stage 0 and breast cancer (invasive ductal carcinoma, invasive lobular carcinoma, and Paget disease) with stage 0-IIA, endometrial cancer (endometrioid adenocarcinoma and mucinous adenocarcinoma) with stage I, prostate cancer (adenocarcinoma) with stae I-II, cervical cancer (squamous cell carcinoma) with stage 0, thyroid cancer (papillary carcinoma and follicular carcinoma) with stage I-III, and renal cancer (clear cell carcinoma and chromophobe cell carcinoma) with stage I.
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) Insulin-dependent or uncontrollable diabetes mellitus.
8) Uncontrollable hypertension.
9) History of severe heart disease, heart failure, myocardial infarction within the past 6 months or attack of angina pectoris within the past 6 months.
10) Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema.

Target sample size

1700

Name of lead principal investigator

1st name	Morihito
Middle name
Last name	Okada

Organization

Hiroshima University Hospital

Division name

Surgical Oncology

Zip code

734-8551

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	(2)Hisashi Saji
Middle name
Last name	(1)Tomoyuki Hishida

Organization

JCOG1413 Coordinating Office

Division name

(1)Keio University School of Medicine (2)St. Marianna University School of Medicine

Zip code

(1)160-8582/(2)216-8511

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN / 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, JAPAN

TEL

(1)03-5363-3806(2)044-977-8111

Homepage URL

http://www.jcog.jp/

Email

JCOG_sir@ml.jcog.jp

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

National Cancer Center Institutional Review Board

Address

5-1-1 Tsukiji, Chuo-ku, Tokyo

Tel

03-3542-2511

Email

NCC_IRBoffice@ml.res.ncc.go.jp

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）
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）
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）
京都大学医学部附属病院（京都府）
大阪大学医学部（大阪府）
大阪国際がんセンター（大阪府）
大阪府立病院機構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

2017

Year

01

Month

05

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

2016

Year

10

Month

04

Day

Date of IRB

2016

Year

11

Month

24

Day

Anticipated trial start date

2017

Year

01

Month

05

Day

Last follow-up date

2033

Year

07

Month

05

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

01

Month

05

Day

Last modified on

2023

Year

10

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028940