UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005503 |
|---|---|
| Receipt number | R000006524 |
| Scientific Title | First-line trial of CBDCA + S-1 + Gefitinib for patients with advanced or reccurent NSCLC patients harboring activating mutation of the EGFR gene -Phase II trial- |
| Date of disclosure of the study information | 2011/05/01 |
| Last modified on | 2017/08/13 09:01:05 |
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Basic information
Public title
First-line trial of CBDCA + S-1 + Gefitinib for patients with advanced or reccurent NSCLC patients harboring activating mutation of the EGFR gene
-Phase II trial-
Acronym
Phase II trial of CBDCA + S-1 + Gefitinib
Scientific Title
First-line trial of CBDCA + S-1 + Gefitinib for patients with advanced or reccurent NSCLC patients harboring activating mutation of the EGFR gene
-Phase II trial-
Scientific Title:Acronym
Phase II trial of CBDCA + S-1 + Gefitinib
Region
| Japan |
Condition
Condition
non small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to investigate the efficacy of CBDCA + S-1 + Gefitinib for patients with advanced or reccurent NSCLC patients harboring activating mutation of the EGFR gene
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
The rate of one year progression free survival (1 year PFS rate)
Key secondary outcomes
response rate
progression free survival (PFS)
overall survival (OS)
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
CBDCA + S1 + Gefitinib
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) diagnosis of NSCLC
2) advanced (stage IIIB who can not treat radiation therapy, and stage IV) or reccurent NSCLC patients
3) the patients who have the target region for RECIST v1.1
4) harboring activating mutation of EGFR gene (exon 19 delation, and L858R)
5) non perior chemotherapy, or 1 year or more after adjuvant chemotherapy
6) 20 years old or more
7) PS 0-1
8) good condition of main organ
9) over 12 weeks of lifetime expectancy
10) agreement of informed concent for this trial
Key exclusion criteria
1) the patients who have interstitial change.
2) allergy of the medication
3) double cancer
4) un-controled pleural effusion and ascites
5) severe conplications, including AMI, un-controled angina pectoris, and un-controled diabetis and hypertension
6) synptomatic brain metastasis
7) radiation therapy which has thoracic field
8) the patients who treat with flucytosine
9) the case of pregnancy and lactation
10) the doctors' jundgement of expurgate
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Atagi |
Organization
National hospital organization Kinki-Chuo Chest Medical Center
Division name
thoracic oncology
Zip code
Address
1180, nagasone-cho, kita-ku, sakai-city, osaka
TEL
072-252-3021
s-atagi@kch.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Tamiya |
Organization
National hospital organization Kinki-Chuo Chest Medical Center
Division name
thoracic oncology
Zip code
Address
1180, nagasone-cho, kita-ku, sakai-city, osaka
TEL
072-252-3021
Homepage URL
atamiya@kch.hosp.go.jp
Sponsor or person
Institute
National hospital organization Kinki-Chuo Chest Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
osaka prefectual medical center for respiratory and allergic diseases
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
| 2011 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2011 | Year | 04 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 25 | Day |
Last modified on
| 2017 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006524
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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