UMIN-CTR Clinical Trial

Basic information
Public title	Phase II trial of cisplatin and TS-1 with radiotherapy for patients with locally advanced N2 non-small cell lung cancer
Acronym	Phase II trial of cisplatin and TS-1 with radiotherapy for patients with locally advanced N2 non-small cell lung cancer
Scientific Title	Phase II trial of cisplatin and TS-1 with radiotherapy for patients with locally advanced N2 non-small cell lung cancer
Scientific Title:Acronym	Phase II trial of cisplatin and TS-1 with radiotherapy for patients with locally advanced N2 non-small cell lung cancer
Region	Japan

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

Objectives
Narrative objectives1	evaluate the efficacy and safety of cisplatin and TS-1 with radiotherapy for patients with locally advanced N2 non-small cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	2 years survival rate
Key secondary outcomes	Response rate, Progression-free survival, Overall survival, Surgery transition rate, Rate and incidence of adverse events

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment
Interventions/Control_1	S-1:80mg/m2 (d1-d15) q4w x 4 cycles CDDP:60 mg/m2(d1) q4w x 4 cycles RT: 66 Gy/33frs
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) Patients with histlogically or cytologically confirmed non-small cell lung cancer 2) Prior treatment of radiotherapy, chemotherapy or surgery for Patients with stage IIIA or IIIB 3)Prior treatment of chemoradiotherapy or chemotherapy for non-small cell lung cancer patients for up to 1 regimen in the EGFR-TKI untreated 4) Unresectable lung cancer 5) 20<=, <80years old 6)PS:0-1 (ECOG) 7)adequate bone marrow,liver,and renal functions WBC count >= 4,000/mm3, Neutrophil counts >= 2,000/mm3 Platelets >= 100,000/mm3 Hemoglobin concentration >= 9.0g/dL Total bilirubin <= 1.5mg/dL AST and ALT >=100IU/L SpO2(Room air) >=90% Creatinine clearance >= 60 mL/min, 8)written informed consent
Key exclusion criteria	1) SVC syndrome 2)Active infection more than and equal to grade 2 3) Continuous watery diarrhea 4) Significant comorbid disease such as paresis of intestine, ileus, interstitial pneumonia, lung fibrosis, uncontrolled diabetes mellitus, cardiac failure, renal failure, hepatic failure, active gastrointestinal ulcer, myocardial infarction and angina pectoris within 6 months, other uncontrolled disease 5) Continuous administration of a steroid 6) Active concomitant malignancy except carcinoma in situ, intramucosal carcinoma or cancer with more than 5 year disease free 7) Pregnant status or lactation 8) Uncontrolled psychiatric disease 9) Patients required for continuing steroid therapy 10) Severe drug allergy 11) Being treated with flucytosine. 12)Participation in other registration trial before randomization in this trial 13) Any patients judged by the investigator to be unfit to participate in the study
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Middle name Last name Toshinari Ema
Organization	Itabashi central medical center
Division name	Department of Thoracic Surgery
Zip code
Address	2-12-7 Azusawa, Itabashi, Tokyo 174-0051
TEL	03-3967-0572
Email	toshinariema09@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Toshinari Ema
Organization	Itabashi central medical center
Division name	Department of Thoracic Surgery
Zip code
Address	2-12-7 Azusawa, Itabashi, Tokyo 174-0051
TEL	03-3967-0572
Homepage URL
Email	toshinariema09@yahoo.co.jp

Sponsor
Institute	Itabashi central medical center
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	2013 Year 12 Month 02 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	2013 Year 12 Month 02 Day
Date of IRB
Anticipated trial start date	2013 Year 12 Month 02 Day
Last follow-up date	2016 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 12 Month 02 Day
Last modified on	2013 Year 12 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014575

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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