UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001765 |
|---|---|
| Receipt number | 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 11:53:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
tokujiro@surg2.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University,Graduate School of Medical Science,Department of Surgery and Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001984
