UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007242 |
|---|---|
| Receipt number | 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 13:06:35 |
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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
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
nnogami@shikoku-cc.go.jp
Sponsor or person
Institute
National Hospital Organization
Shikoku Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008463
