UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042905 |
|---|---|
| Receipt number | 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 11:31:01 |
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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
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/
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）
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047516
