UMIN-CTR Clinical Trial

Basic information
Public title	A randomized phase II trial of induction CDDP +PEM +BEV versus CDDP + PEM with concurrent radiotherapy followed by surgical resection in patients with pathologically confirmed stage IIIA-N2 non-squamous- cell non-small cell lung cancer
Acronym	Personalized Induction Therapy Clinical Trial-1:PIT-1
Scientific Title	A randomized phase II trial of induction CDDP +PEM +BEV versus CDDP + PEM with concurrent radiotherapy followed by surgical resection in patients with pathologically confirmed stage IIIA-N2 non-squamous- cell non-small cell lung cancer
Scientific Title:Acronym	Personalized Induction Therapy Clinical Trial-1:PIT-1
Region	Japan

Condition
Condition	Stage IIIA-N2 Non-squamous, Non-small cell lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safty of preoperative induction concurrent chemoradiotherapy(CDDP + PEM + RT45Gy) and preoperative induction chemotherapy (CDDP + PEM + BEV) for Stage IIIA-N2 non-squamous, non-small cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	2-year progression-free survival
Key secondary outcomes	5-year progression-free survival 2-year and 5-year overall survival Completion rate of the protocol treatment Complete resection rate Radiological response rate Down staging rate Safety Pathological response (Ef) Tumor markers (CEA/CYFRA) SUVmax on FDG-PET scan

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	"Group A : Induction chemotherapy (CDDP + PEM + BEV) The surgical resection is performed after 3 cycles of chemotherapy with CDDP, PEM, and bevacizumab. "
Interventions/Control_2	"Group B :Induction concurrent chemoradiotherapy (CDDP + PEM + RT45Gy) The surgical resection is performed after 3 cycles of chemotherapy with CDDP, PEM and RT45Gy. "
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
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Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	"1. Histologically or cytologically proven non-squamous non-small cell lung cancer, diagnosed using specimen material obtained from primary tumor or metastastatic lymph node 2. Stage IIIA- pathologically proven N2 disease 3. Without previously treatment for lung cancer 4. Age 20-75 y 5. ECOG PS 0-1 6. Expected FEV 1.0 ,over800ml after lung resection, SpO2 Room air over95% 7. Adequate organ function 8. Written informed consent "
Key exclusion criteria	"1.Uncontrollable systemic disease.hyper tension, diabetes mellitus etc. 2. Current history of hemosputum or hemoptysis 3. Evidence of bleeding diathesis or coagulopathy 4. Cavity in lung tumor or great vessel involvement 5. Current or previous within the last 1 year history of cerebrovascular disease 6. Traumatic fracture of un recovery 7. History of active infection 8. hepatitis B surface antigen positive 9. Therapeutic anticoagulation; regular use of aspirin ,over 325 mg/day. 10. Severe GI disease 11. Current or previous within the last 1 year history of GI perforation or diverticultis 12. History of severe heart disease 13. Severe diarrhea 14. Severe drug allergy 15. Investigational new drug or the unapproved drug is administered 16. Interstitial pneumonia or pulmonary fibrosis detectable on chest Xp 17. History of active double cancer 18. History of pregnancy or lactation 19. Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator "
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Middle name Last name Morihito Okada
Organization	Hiroshima University
Division name	Thoracic Surgery
Zip code
Address	1-2-3 kasumi minami-ku Hiroshima,Hiroshima
TEL	082-257-5869
Email	morihito@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kazuya Takamochi
Organization	Juntendo University
Division name	Thoracic Surgery
Zip code
Address	3-1-3Hongo Bunkyo-ku,Tokyo
TEL	03-3813-3111
Homepage URL
Email	ktakamo@juntendo.ac.jp

Sponsor
Institute	Advanced Clinical Trial chest surgery Group (ACTG)
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
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IRB Contact (For public release)
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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	大分大学医学部附属病院（大分県） がん・感染症センター都立駒込病院（東京都） がん研有明病院（東京都） 岐阜大学医学部附属病院（岐阜県） 倉敷中央病院（岡山県） 神戸大学医学部附属病院（兵庫県） 国立がん研究センター東病院（千葉県） 産業医科大学病院（福岡県） 順天堂大学医学部附属順天堂医院（東京都） 聖マリアンナ医科大学病院（神奈川県） 仙台厚生病院（宮城県） 東京医科大学病院（東京都） 鳥取大学医学部附属病院（鳥取県） 広島市立広島市民病院（広島県） 広島大学病院（広島県） 福島県立医科大学附属病院（福島県） 山形県立中央病院（山形県） 山口大学医学部附属病院（山口県） 横浜市立大学付属市民総合医療センター（神奈川県）

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 02 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Results
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Baseline Characteristics
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IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 08 Month 16 Day
Date of IRB
Anticipated trial start date	2013 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 10 Month 02 Day
Last modified on	2018 Year 09 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013941

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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