UMIN-CTR Clinical Trial

Basic information
Public title	A phase II trial of induction CDDP plus TS-1 with concurrent radiotherapy followed by surgical resection in patients with resectable stage IIIA-N2 non-small cell lung cancer
Acronym	A phase II trial of induction chemoradiotherapy followed by surgery in patients with resectable stage IIIA-N2 NSCLC
Scientific Title	A phase II trial of induction CDDP plus TS-1 with concurrent radiotherapy followed by surgical resection in patients with resectable stage IIIA-N2 non-small cell lung cancer
Scientific Title:Acronym	A phase II trial of induction chemoradiotherapy followed by surgery in patients with resectable stage IIIA-N2 NSCLC
Region	Japan

Condition
Condition	Stage IIIA-N2 non-small cell lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To validate the safety and efficacy of induction CDDP plus TS-1 with concurrent radiotherapy followed by surgery in patients with stage IIIA-N2 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 overall survival
Key secondary outcomes	Overall survival Progression-free survival Postoperative recurrence free survival Response rate Pathological complete response rate Frequency and grade of adverse event

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Induction concurrent chemoradiotherapy (CDDP +TS-1+ RT50Gy) The surgical resection is performed after 2 cycles of chemotherapy with CDDP, TS-1 and RT50Gy.
Interventions/Control_2
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1)Histologically or cytologically proven non-small cell lung cancer, diagnosed using specimen material obtained from primary tumor or metastastatic lymph node 2)Stage IIIA- resectable N2 disease without previously treatment for lung cancer 3)Age>=20, <75 y 4)Patient who can ingest orally 5)ECOG PS 0-1 6)Adequate organ function neutrophil count>=2,000/mm3 blood platelet count>=100,000/mm3 hemoglobin>=9.0g/dL total bilirubin<=1.5mg/dL AST,ALT<=100IU/L PaO2>=60Torr or SpO2>=94% CCr>=60ml/min 7)Written informed consent
Key exclusion criteria	1)History of active infection 2)Severe diarrhea 3)Severe complication (Severe GI disease, bowel obstruction, interstitial pneumonia or pulmonary fibrosis detectable on chest Xp, uncontrollable diabetes mellitus, history of severe heart disease, severe renal disease, severe hepatic disease, Current history of GI ulcer, Current history of myocardial infarction and angina pectoris) 4)Autoimmune disease requiring immunosuppressive agent 5)History of active double cancer 6)History of pregnancy or lactation 7)History of psychiatric disorder 8)Systemic administration of steroid 9)Severe drug allergy 10) Hepatitis Bc antibody or hepatitis Bs antigen positive 11)Administration of flucytosine 12)Investigational new drug or the unapproved drug is administered 13)Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kimihiro Shimizu
Organization	Gunma University Hospital
Division name	General Thoracic Surgery, Integrative center of general surgery
Zip code
Address	3-39-15 Showa-machi, Maebashi, Gunma
TEL	027-220-8245
Email	kmshimizu@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Yoichi Ohtaki
Organization	Gunma University Hospital
Division name	General Thoracic Surgery, Integrative center of general surgery
Zip code
Address	3-39-15 Showa-machi, Maebashi, Gunma
TEL	027-220-8245
Homepage URL
Email	yohtakiadvanced@gmail.com

Sponsor
Institute	Gunma University Hospital
Institute
Department

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

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

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 30 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	Terminated
Date of protocol fixation	2014 Year 10 Month 01 Day
Date of IRB	2014 Year 10 Month 01 Day
Anticipated trial start date	2015 Year 07 Month 09 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 06 Month 30 Day
Last modified on	2019 Year 07 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020996