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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042905
Receipt No. R000047516
Scientific Title Postoperative radiotherapy (PORT) for pathological N2 non-small cell lung cancer with adjuvant chemotherapy: a randomized phase III trial
Date of disclosure of the study information 2021/01/05
Last modified on 2021/01/05

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Basic information
Public title Postoperative radiotherapy (PORT) for pathological N2 non-small cell lung cancer with adjuvant chemotherapy: a randomized phase III trial
(JCOG1916, J-PORT)
Acronym Postoperative radiotherapy (PORT) for pathological N2 non-small cell lung cancer with adjuvant chemotherapy: a randomized phase III trial
(JCOG1916, J-PORT)
Scientific Title Postoperative radiotherapy (PORT) for pathological N2 non-small cell lung cancer with adjuvant chemotherapy: a randomized phase III trial
Scientific Title:Acronym Postoperative radiotherapy (PORT) for pathological N2 non-small cell lung cancer with adjuvant chemotherapy: a randomized phase III trial
Region
Japan

Condition
Condition pathological N2 non-small cell lung cancer
Classification by specialty
Chest surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this randomized phase III study is to confirm the superiority, in terms of relapse-free survival, of radiotherapy over observation after postoperative chemotherapy in patients with pathological N2 stage III 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 relapse-free survival
Key secondary outcomes overall survival, proportion of patients completing radiotherapy in arm B, early adverse events, late adverse events in arm B, severe adverse events, local recurrence

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
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: Observation
Interventions/Control_2 B: Thoracic radiotherapy
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 (1)Histologically confirmed NSCLC via surgical specimens
(2)Diagnosed as clinical N0-1 prior to surgery but diagnosed as pathological N2 after surgery
(3)Complete resection (R0) is histologically confirmed via surgical specimens
(4)No satellite tumors
(5)Lobectomy is performed for the primary tumor
(6)Systematic or lobe-specific lymph node dissection is performed
(7)Aged 20 years or older at the time of registration
(8)Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
(9)No prior segmentectomy or lobectomy of the lung other than the resection of the primary tumor
(10)No prior chemotherapy other than the postoperative chemotherapy for the primary tumor
(11)No prior radiotherapy to the chest
(12)More than one course of any of the following regimens is administered for the postoperative chemotherapy without Grade 4 non-hematologic adverse events or drug-induced pneumonitis
(a)Cisplatin plus vinorelbine
(b)Cisplatin plus docetaxel
(c)Cisplatin plus pemetrexed
(13)Within 56 days after postoperative chemotherapy for the primary tumor
(14)No sign of relapse on head, thoracic, and abdominal contrast-enhanced CT after completion of postoperative chemotherapy
(15)No sign of interstitial pneumonia on CT and by histological evaluation of the surgical specimen
(16)Can undergo radiotherapy according to the protocol
(17)Sufficient organ function
(a)White blood cell count >= 3,000/mm3, <= 12,000/mm3
(b)Hemoglobin >= 9.0g/dL
(c)Platelet count >= 80,000/mm3
(d)Total bilirubin <= 1.5 mg/dL
(e)Aspartate aminotransferase <= 100 U/L
(f)Alanine aminotransferase <= 100 U/L
(g)Creatinine <= 1.5 mg/dL
(h)SpO2 >= 93% (room air)
(18)No sign of ischemic heart disease on the latest electrocardiogram findings
(19)Written informed consent
Key exclusion criteria (1)History of synchronous or metachronous (within 3 years) malignancies
(2)Active infection requiring systemic therapy
(3)Fever with a body temperature higher than 38.0 degrees Celsius at the time of registration
(4)Pregnant, possibly pregnant, within 28 days of delivery, breastfeeding females, or males expecting to father a child
(5)Psychiatric illnesses or symptoms affecting the daily lives
(6)Systemic treatment with steroids or immunosuppressive agents
(7)Unstable angina(diagnosis or worsening of chest pain within 3 weeks) or history of myocardial infarction within 6 months prior to the registration
Target sample size 330

Research contact person
Name of lead principal investigator
1st name Shun-ichi
Middle name
Last name Watanabe
Organization National Cancer Center Hospital
Division name Division of Thoracic Surgery
Zip code 104-0045
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Email JCOG_sir@ml.jcog.jp

Public contact
Name of contact person
1st name Kazuo
Middle name
Last name Nakagawa
Organization JCOG1916 Coordinating Office
Division name Division of Thoracic Surgery, National Cancer Center Hospital
Zip code 104-0045
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511(7041)
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 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
Email 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)
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)
東京慈恵会医科大学附属病院(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)
北里大学医学部(神奈川県)
新潟県立がんセンター新潟病院(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)
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)
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)

Other administrative information
Date of disclosure of the study information
2021 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
2020 Year 08 Month 31 Day
Date of IRB
2020 Year 12 Month 17 Day
Anticipated trial start date
2021 Year 01 Month 05 Day
Last follow-up date
2032 Year 01 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
2021 Year 01 Month 05 Day
Last modified on
2021 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047516

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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