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Recruitment status
Unique ID issued by UMIN UMIN000001928
Receipt No. R000002349
Scientific Title Phase II trial of preoperatively CDDP/S-1 for patients with clinical stage II(exclusion N0 disease) and Stage IIIA non-small cell lung cancer
Date of disclosure of the study information 2009/05/01
Last modified on 2009/05/01

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Basic information
Public title Phase II trial of preoperatively CDDP/S-1 for patients with clinical stage II(exclusion N0 disease) and Stage IIIA non-small cell lung cancer
Acronym Induction chemotherapy of CDDP/S-1 for patients with stage II or IIIA non-small cell lung cacer
Scientific Title Phase II trial of preoperatively CDDP/S-1 for patients with clinical stage II(exclusion N0 disease) and Stage IIIA non-small cell lung cancer
Scientific Title:Acronym Induction chemotherapy of CDDP/S-1 for patients with stage II or IIIA non-small cell lung cacer
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To investigate the efficacy of preoperative CDDP/S-1 and the relation to biomarkers for patients with II, IIIA advanced non-small cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Analysis of regulation factors from lymph node samples usng EBUS-TBNA and relation to radiological, histological response rate after induction chemotherapy
Key secondary outcomes feasibility, progression free survival, overall survival,and 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 Preoperatively induction chemotherapy
(CDDP/S-1)
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)Histlogically confirmed non-small cell lung cancer
2)In principles, resectable stage II (exculde N0 disease) and stage IIIA patients by lobectomy, histologically or cytologically diagnosed N-factor using EBUS-TBNA
3)N2 disease without extra-nodal invasion
4)>=20, <75 years of age
4)feasible oral consumption
5)Performance statas 0 or 1 cases (ECOG scale)
6)Without previous therapy (operation, rdiotherapy, chemotherapy etc.) for non^small cell lung cancer
7)preserved organ's function within 2 weeks before registration.
KL-6: normal
WBC: more than 4000/m3
Neutorocytes: more than 2000/m3
Platelet: more than 100,000/m3
Hb: 9.0 more than g/dl
AST(GOT), ALT(GPT): less than 100 IU/L
T-bil: less than 1.5 md/dL
PaO2: more than 70 Torr
Ccr: 60mL/min
[Cockcroft-Gault]
male Ccr=body weight(BW)X(140-age)/(72 X serum Cre)
female Ccr=BW X (140-age)/(72 X serum Cre)X 0.85
8)Written informed consent
Key exclusion criteria 1)Patients with severe drug allergy
2)Patients with administration of another 5-fluouracil derivative drugs, flucytosine, phenytoin, warfarin sodium
3)Patients with active concomitant malignancy
4)Patients with active severe infection, diarrhea, interstinalparalysis, ileus, uncontrolled diabetes mellitus, uncontrolled angina, myocardial infarction within 6 months from onset, heart failure, other severe complications
5)Patients with active lung disease such as idopathic pulmonary fibrosis, pulmonary emphysema, severe chronic bronchitis, bronchial asthma
6)Patients with uncontrollable psychiatrical complications
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ichiro Yoshino
Organization Graduate School of Medicine, Chiba University
Division name Thoracic Surgery
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Graduate School of Medicine, Chiba University
Division name Thoracic Surgery
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Thoracic Surgery, Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization Thoracic Surgery, Graduate School of Medicine, Chiba University
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 05 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
Date of protocol fixation
2008 Year 12 Month 12 Day
Date of IRB
Anticipated trial start date
2008 Year 12 Month 01 Day
Last follow-up date
2015 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
2009 Year 05 Month 01 Day
Last modified on
2009 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002349

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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