UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011345 |
|---|---|
| Receipt number | R000013295 |
| Scientific Title | Feasibility study of adjuvant chemotherapy with cisplatin(CDDP) and TS-1 in followed by alternate-day treatment with TS-1 in patients with completely resected pathological II-IIIA non small cell lung cancer |
| Date of disclosure of the study information | 2013/08/01 |
| Last modified on | 2014/02/03 23:55:16 |
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Basic information
Public title
Feasibility study of adjuvant chemotherapy with cisplatin(CDDP) and TS-1 in followed by alternate-day treatment with TS-1 in patients with completely resected pathological II-IIIA non small cell lung cancer
Acronym
Feasibility study of adjuvant chemotherapy with cisplatin(CDDP) and TS-1 in followed by alternate-day treatment with TS-1 in patients with completely resected pathological II-IIIA non small cell lung cancer
Scientific Title
Feasibility study of adjuvant chemotherapy with cisplatin(CDDP) and TS-1 in followed by alternate-day treatment with TS-1 in patients with completely resected pathological II-IIIA non small cell lung cancer
Scientific Title:Acronym
Feasibility study of adjuvant chemotherapy with cisplatin(CDDP) and TS-1 in followed by alternate-day treatment with TS-1 in patients with completely resected pathological II-IIIA 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
To explore feasibility of cisplatin(CDDP) and TS-1 in followed by alternate-day treatment with TS-1 in patients with completely resected pathological II-IIIA non small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The completion rate of protocol treatment
Key secondary outcomes
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
CDDP 60mg/m2 ,day1
TS-1 80mg/m2 ,day1-14
q3-4weeks , 3 cycles
TS-1 80mg/m2 alternate-day administrations : TS-1 is administered orally at Monday, Wednesday, Friday and Sunday from start of administration day to the day corresponding to one year after surgery.
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) Pathologically confirmed diagnosis of NSCLC.
2) Non-small cell lung cancer with stage II-IIIA
3) Completely resected
4) Oral intake
5) LN dissection more than ND2a-1
6) Neither previous chemotherapy nor radiotherapy before operation
7) Performance Status (ECOG) 0-2
8) Aged 20-75 years old
9)Have adequate organ function within 14 days before study entry
a.Leukocyte count 3,000/mm3 or over
b.Granulocyte count 1,500/mm3 or over
c.Platelet count 100,000/mm3 or over
d.Hb 9.0 g/dl or over
e.AST(GOT) 2.5 x the Upper Limits of Normal(ULN) or under
f.ALT(GPT) 2.5 x the Upper Limits of Normal (ULN) or under
g.Total bilirubin 1.5 mg/dL or under
h.Serum creatinine 1.5 mg/dl or under
i. creatinine clearance 50 mL / min or over
j.PaO2 60torr or over or SpO2 90% or over
10) Written informed consent to participate.
11) Possible to receive chemotherapy within 8 months after surgery
Key exclusion criteria
1)Anamnesis of hypersensitivity to drugs
2)Massive pleural or pericardial effusion
3) With active double cancer
4)Severe complication (ileus , interstitial pneumonia , interstitial pneumonia , pulmonary fibrosis, uncontrolled diabetes , heart failure , renal failure, hepatic failure, and so on)
5) With active infections
6) With a difficult bowel movement
7) Pleural effusion, cardiac effusion, or cardiac effusion necessitating treatment.
8) Pregnancy or lactating patients
9) Uncontrolled psychiatric disease
10)With poor-controlled diabetes mellitus
11) Concurrent steroid therapy
12) With HBs or HCV
13) With HIV
14) Physician judged improper to entry this trial
Target sample size
58
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Suzuki |
Organization
Faculty of Life Science Kumamoto University
Division name
Department of Thoracic Surgery
Zip code
Address
1-1-1 Honjo,chuo-ku ,Kumamoto
TEL
096-373-5533
smakoto@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro Yoshimoto |
Organization
Minami Kyushu National Hospital
Division name
Department of Thoracic Surgery
Zip code
Address
1882, Kajikicho Kida, Aira-shi, Kagoshima, 899-5241, Japan
TEL
0995-62-2121
Homepage URL
yoshiken-2@umin.org
Sponsor or person
Institute
Department of Thoracic Surgery , Faculty of Life Science Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 01 | 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 | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 01 | Day |
Last modified on
| 2014 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013295
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