UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001928 |
|---|---|
| Receipt number | 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 17:28:55 |
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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
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
Sponsor or person
Institute
Thoracic Surgery, Graduate School of Medicine, Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002349
