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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012455
Receipt No. R000014575
Scientific Title Phase II trial of cisplatin and TS-1 with radiotherapy for patients with locally advanced N2 non-small cell lung cancer
Date of disclosure of the study information 2013/12/02
Last modified on 2013/12/02

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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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