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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000001765
Receipt No. R000001984
Scientific Title A phase II randomized trial of adjuvant chemotherapy for the patients completely resected pathological stage IB(T>5cm), II, IIIA Non Small Cell Lung Cancer comparing S-1 / S-1 with CDDP
Date of disclosure of the study information 2009/03/12
Last modified on 2009/12/30

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Basic information
Public title A phase II randomized trial of adjuvant chemotherapy for the patients completely resected pathological stage IB(T>5cm), II, IIIA Non Small Cell Lung Cancer comparing S-1 / S-1 with CDDP
Acronym A phase II randomized trial of adjuvant chemotherapy for the patients Non Small Cell Lung Cancer comparing S-1 / S-1 with CDDP
Scientific Title A phase II randomized trial of adjuvant chemotherapy for the patients completely resected pathological stage IB(T>5cm), II, IIIA Non Small Cell Lung Cancer comparing S-1 / S-1 with CDDP
Scientific Title:Acronym A phase II randomized trial of adjuvant chemotherapy for the patients Non Small Cell Lung Cancer comparing S-1 / S-1 with CDDP
Region
Japan

Condition
Condition non-small cell lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To select the arms for the phase III trial in stage IB (T>5cm), II, and IIIA Non-Small-Cell Lung Cancer by comparing S-1 / S-1 with CDDP
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes 2-year desease free survival rate
Key secondary outcomes overall survival,desease free survival,safety,feasibility(dose intensity included)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A:S-1 80mg/m2 oral,day1 to 14,q3w,1year
If the patient's Ccr estimate is 60-80mL/min,to start the first dose to reduce one level down
Interventions/Control_2 B:S-1 80mg/m2 oral day1 to 21,q5w+CDDP 60mg/m2 day8,q5w,4 courses,followed by S-1 80mg/m2 oral day1 to 14,q3w,total 1year
If the patient's Ccr estimate is 60-80mL/min, to start the first dose to reduce one level down
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)histologically conformed Non Small Cell Lung Cancer
(2)pathological stage IB (T>5cm) II or IIIA completely resected by at least lobectomy
(3)LN dissection (ND2a) or Elective Lymph Node Dissection
(4)no prior chemotherapy or radiotherapy
(5)possible to receive chemotherapy within 4-8 weeks after surgery
(6)oral intake possible
(7)PS of 0 or 1
(8)age 20-75
(9)adequate organ function
1)WBC>=3500/mm3<=12000/mm3
2)Neutrophil count>=2000/mm3<=8000/mm3
3)Platelet count>=100000/mm3
4)Hemoglobin>=9.0g/dl
5)AST,ALT within twice the upper limit of normal of institution
6)total bilirubin < 1.5 mg/dl
7)creatinin < 1.2 mg/dl
8)creatinin clearance>=60ml/min/body
9)PaO2>=60 torr or SpO2>=92%
(10)written informed consent
Key exclusion criteria (1)A history of severe allergic reactions to drugs
(2)Patients who have already received CDDP,S-1
(3)myocardial infarction within 6 months
(4)apparent interstitial pneumonitis or pulmonary fibrosis
(5)Patients with an unstable or serious heart disease
(6)Patients with an unstable or serious psychic disease
(7)uncontrolled diabetes mellitus
(8)Patients with Paralysis of intestine or ileus
(9)Patients with an active infection
(10)Patients with other severe complication
(11)The presence of other concomitant or metachronous cancers
(12)Pregnant or expecting or lactating woman
(13)Male patient who intends to make someone pregnant during this study
(14)Patient who requires continuous use of flucytosine , phenytoin or warfarin potassium
(15)systemic steroid therapy required
(16)Patient who is judged to be inappropriate as subject to this study by the principal investigator
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiko Maehara
Organization Kyushu University,Graduate School of Medical Science
Division name Department of Surgery and Science
Zip code
Address 3-1-1 Maidashi Higashi-ku Fukuoka 812-8582 JAPAN
TEL 092-642-5462
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tokujiro Yano
Organization Kyushu University,Graduate School of Medical Science
Division name Department of Surgery and Science
Zip code
Address 3-1-1 Maidashi Higashi-ku Fukuoka 812-8582 JAPAN
TEL 092-642-5462
Homepage URL
Email tokujiro@surg2.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University,Graduate School of Medical Science,Department of Surgery and Science
Institute
Department

Funding Source
Organization Kyushu University,Graduate School of Medical Science,Department of Surgery and Science
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
2009 Year 03 Month 12 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
2008 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2008 Year 10 Month 01 Day
Last follow-up date
2015 Year 09 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
2009 Year 03 Month 11 Day
Last modified on
2009 Year 12 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001984

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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