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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011345
Receipt No. 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

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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
Email 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
Email yoshiken-2@umin.org

Sponsor
Institute Department of Thoracic Surgery , Faculty of Life Science Kumamoto University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013295

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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