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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025530
Receipt No. R000028940
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)
Date of disclosure of the study information 2017/01/05
Last modified on 2018/02/14

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Basic information
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
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

Objectives
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

Assessment
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.

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 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

Eligibility
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

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshima University Hospital
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

Public contact
Name of contact person
1st name
Middle name
Last name (1)Tomoyuki Hishida (2)Hisashi Saji
Organization JCOG1413 Coordinating Office
Division name (1)Keio University School of Medicine (2)St. Marianna University School of Medicine
Zip code
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

Sponsor
Institute Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
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
Address
Tel
Email

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)
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)

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 05 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
2016 Year 10 Month 04 Day
Date of IRB
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
Other related information

Management information
Registered date
2017 Year 01 Month 05 Day
Last modified on
2018 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028940

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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