UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040089 |
|---|---|
| Receipt number | R000045327 |
| Scientific Title | Anatomical segmentectomy versus wedge resection in high-risk operable patients with clinical stage IA non-small cell lung cancer: A randomized phase III trial. |
| Date of disclosure of the study information | 2020/04/07 |
| Last modified on | 2020/04/07 11:44:13 |
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Basic information
Public title
Anatomical segmentectomy versus wedge
resection in high-risk operable patients with
clinical stage IA non-small cell lung cancer:
A randomized phase III trial.
(JCOG1909, ANSWER)
Acronym
Anatomical segmentectomy versus wedge
resection in high-risk operable patients with
clinical stage IA non-small cell lung cancer:
A randomized phase III trial.
(JCOG1909, ANSWER)
Scientific Title
Anatomical segmentectomy versus wedge
resection in high-risk operable patients with
clinical stage IA non-small cell lung cancer:
A randomized phase III trial.
Scientific Title:Acronym
Anatomical segmentectomy versus wedge
resection in high-risk operable patients with
clinical stage IA non-small cell lung cancer:
A randomized phase III trial.
Region
| Japan |
Condition
Condition
clinical stage IA non-small cell lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this randomized trial is to confirm the superiority of anatomical segmentectomy to wedge resection in overall survival for high-risk operable patients with clinical stage IA non-small cell lung cancer.
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
Adverse events, postoperative respiratory function, relapse-free survival, proportion of local recurrences, operation time, blood loss.
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:Wedge resection
Interventions/Control_2
B:Anatomical segmentectomy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria at primary registration
(1)Fulfills all the following conditions on imaging studies
(i)cT1N0M0 NSCLC is suspected
(ii)Center of the tumor is located in the outer third of the lung field.
(iii)Maximum diameter of the tumor <= 3 cm
(iv)C/T ratio is > 0.5
(2)No satellite tumors
(3)Fulfills the definition for high-risk in lung lobectomy (fulfills more than one major criterion or more than 2 minor criteria)
Major criteria
(a)%FEV1 <= 50%
(b)%DLCO <= 50%
Minor criteria
(c)Aged 75 years or older
(d)%FEV1 > 50% and %FEV1 <= 60%
(e)%DLCO > 50% and %DLCO <= 60%
(f)Pulmonary hypertension
(g)Left ventricular dysfunction
(h)PaO2 <= 55 mmHg or SpO2 <= 88%
(i)PaCO2 > 45 mmHg
(j)Modified Medical Research Council Dyspnea Scale grade 3 or higher
(4)Negative for neuroendocrine tumor if cytology tests are performed
(5)Aged 20 years or older
(6)PS of 0 to 1
(7)No prior medical treatment for any type of tumor in the past 2 years (hormone therapy is allowed)
(8)No prior radiation therapy on the lungs, hilum or mediastinum
(9)Fulfills both of the following conditions
(i)Predicted postoperative %FEV1 >= 30%
(ii)Predicted postoperative %DLCO >= 30%
(10)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
(11)No sign of ischemia on latest ECG.
(12)Written informed consent.
Secondary registration (intraoperative) criteria
(1)Within 14 days of the primary registration
(2)Histological confirmation of NSCLC before surgery or during surgery by diagnostic wedge resection or needle biopsy.
(3)Technically possible to perform wedge resection and anatomical segmentectomy.
(4)No signs of malignant effusion, dissemination, regional lymph node metastasis, and direct invasion into surrounding organs except for adjacent lung regions.
Key exclusion criteria
(1) History of synchronous or metachronous (within 2 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 (HbA1c > 8%).
(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
370
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Suzuki |
Organization
Juntendo University
Division name
Division of Thoracic Surgery
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan.
TEL
03-3813-3111
JCOG_sir@ml.jcog.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Tsutani |
Organization
JCOG1909 Coordinating Office
Division name
Surgical Oncology, Hiroshima University Hospital
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5869
Homepage URL
http://www.jcog.jp/
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
Japan
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
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）
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）
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）
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）
大阪はびきの医療センター（大阪府）
国立病院機構近畿中央呼吸器センター（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 | 04 | Month | 07 | 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 | 02 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2031 | Year | 04 | Month | 07 | 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 | 04 | Month | 07 | Day |
Last modified on
| 2020 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045327
