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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007242
Receipt No. R000008463
Scientific Title A Phase II Clinical Trial of CBDCA and TS-1 concurrent chemotherapy followed by TS-1 Maintenance Therapy for Advanced and Recurrent Squamous Cell Lung Cancer: SMILE Trial
Date of disclosure of the study information 2012/02/07
Last modified on 2019/02/17

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Basic information
Public title A Phase II Clinical Trial of CBDCA and TS-1 concurrent chemotherapy followed by TS-1 Maintenance Therapy for Advanced and Recurrent Squamous Cell Lung Cancer: SMILE Trial
Acronym A Phase II Clinical Trial of CBDCA and TS-1 concurrent chemotherapy followed by TS-1 Maintenance Therapy for Advanced and Recurrent Squamous Cell Lung Cancer: SMILE Trial
Scientific Title A Phase II Clinical Trial of CBDCA and TS-1 concurrent chemotherapy followed by TS-1 Maintenance Therapy for Advanced and Recurrent Squamous Cell Lung Cancer: SMILE Trial
Scientific Title:Acronym A Phase II Clinical Trial of CBDCA and TS-1 concurrent chemotherapy followed by TS-1 Maintenance Therapy for Advanced and Recurrent Squamous Cell Lung Cancer: SMILE Trial
Region
Japan

Condition
Condition Non-small cell lung cancer (squamous cell carcinoma)
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of carboplatin and S-1 followed by S-1 maintenance therapy for advanced or recurrent non-small cell lung cancer (squamous cell carcinoma)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes 1-year survival rate
Key secondary outcomes Progression free survival(PFS)
Overall survival (OS)
Objective response rate (ORR)
Safety

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
Interventions/Control_1 Induction chemothrapy
Carboplatin: AUC=5, day 1
TS-1: 80mg/m2, day 1-14
q4w, 4 cycles

Maintenance chemotherapy
TS-1 maintenance: 80mg/m2, day 1-14
q4w, Until PD
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) Histological or cytological confirmed
squamous cell lung carcinoma.
2) Patients with unresectable stageIIIb-
IV or postoperative recurrence.
3) Over 20 yeas old, under 75 years old.
4) ECOG PS 0-1.
5) Patients have the prospective for
surviving more than 3 months.
6) Patients who are able to take oral
medication.
7) Adequate main organ and bone marrow
function filled below criteria within
14 days before registration.
1. Leukocyte counts >= 4,000/mm3
<=12,000 /mm3
2. Neutrophil counts>=1,500 /mm3
3. Platelets >= 100,000 /mm3
4. Hemoglobin >=9.0 g/dL
5. Total bilirubin <= 1.5 mg/dL
6. AST and ALT <= 100 IU/L
7. PaO2 >= 60 Torr or SpO2 >= 90%
8. Serum creatinin clearance
>= 60 ml/min (Cockcroft-Gault)
8) Patients providing written informed
consent.
Key exclusion criteria 1) Any previous first line treatment
with radiotherapy (including chemo
radiotherapy)
2) Administration contraindication to
Carboplatin and S-1.
3) Severe complications, such as cardiac
failure, renal failure, hepatic
failure, hemorrhagic gastric or
duodenal ulcer, ileus, and
uncontrollable or insulin-treated
diabetic.
4) Severe drug allergies or history of
drug hypersensitivity
5) Symptomatic or apparent interstitial
pneumonia/lung fibrosis on CT scan or
X-ray image findings (Included
positive suspicion or history of
them).
6) Severe watery diarrhea
7) With active infection. Fever higher
than 38 degrees celsius.
8) HBsAg positive patients
9) The brain metastases which require
emergent treatment.
10) Patients with ascites, pleural or
pericardial effusion requiring
drainage.
11) Patients undergoing UFT or TS-1
adjuvant therapy. The case
postoperative recurrence within 6
months after adjuvant therapy.
12) Active concomitant malignancy with
disease-free duration to be within 3
years.
13) Required to continue Flucytosine (5-
FC), phenytoin and warfarinpotassium.
14) Pregnant, lactating or women of
child-bearing potential. Men who want
get partner pregnant.
15) The case that is judged to be
inadequacy for this study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsu Shinkai, M.D., Ph.D
Organization National Hospital Organization
Shikoku Cancer Center
Division name Department of thoracic oncology and medicine
Zip code
Address 160 Kou Minami-umemoto, Matsuyama, Ehime 791-0280, Japan
TEL 089-999-1111
Email tshinkai@shikoku-cc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoyuki Nogami, M.D., Ph.D
Organization National Hospital Organization Shikoku Cancer Center
Division name Department of thoracic oncology and medicine
Zip code
Address 160 Kou Minami-umemoto, Matsuyama, Ehime 791-0280, Japan
TEL 089-999-1111
Homepage URL
Email nnogami@shikoku-cc.go.jp

Sponsor
Institute National Hospital Organization
Shikoku Cancer 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 国立病院機構 四国がんセンター(愛媛県松山市)
松山赤十字病院(愛媛県松山市)
市立宇和島病院(愛媛県宇和島市)

Other administrative information
Date of disclosure of the study information
2012 Year 02 Month 07 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 No longer recruiting
Date of protocol fixation
2011 Year 11 Month 25 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
2016 Year 10 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
2012 Year 02 Month 07 Day
Last modified on
2019 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008463

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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