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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000006021
Receipt No. R000007100
Scientific Title Trimodality therapy in EGFR mutation status negative patients with stage IV non-small cell lung cancer
Date of disclosure of the study information 2011/07/31
Last modified on 2015/01/22

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Basic information
Public title Trimodality therapy in EGFR mutation status negative patients with stage IV non-small cell lung cancer
Acronym Trimodality therapy in EGFR mutation status negative patients with stage IV non-small cell lung cancer
Scientific Title Trimodality therapy in EGFR mutation status negative patients with stage IV non-small cell lung cancer
Scientific Title:Acronym Trimodality therapy in EGFR mutation status negative patients with stage IV non-small cell lung cancer
Region
Japan

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

Objectives
Narrative objectives1 Feasibility of induction chemoradiotherapy followed by surgery in EGFR mutation status negative patients with stage IV non-small cell lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Feasibility
Key secondary outcomes OS, PFS, efficacy of chemoradiotherapy and severe adverse effecs of surgery

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
Maneuver
Interventions/Control_1 Induction chemoradiotherapy followed by surgery
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
15 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1)Histologically or cytologically confirmed non-small cell lung cancer.
2)Stage IV lung cancer.
3)EGFR mutation status negative.
4)No prior chemotherapy.
5)N o prior radiotherapy.
6)Resectable primary tumor.
7)More than 16 years old-less than 75 years old.
8)PS0-1
9)At least one or more measurable lesion by RECIST.
10)Adequate organ function.
11)Written Informed Consent.
Key exclusion criteria 1)Active co-morbidities.
2)Symptomatic brain metastasis.
3)Interstitial lung disease.
4)Active infection.
5)Severe heart disease.
6)Massive pleural, cardiac effusion, or ascites needed with treatment.
7)Neurological disorder.
8)Active double cancer.
9)Psychotic disorder.
10)Histology of grave allergic reaction.
11)Pregnancy, breast feeding and supected pregnancy.
12)Patients whose participation in the trial is judged to be inappropriate.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiki Hirata
Organization Iseikai Hospital
Division name Respiratory Disease Center
Zip code
Address Sugawara 6-2-25, Higashiyodogawa-ku, Osaka City, 533-0022, Japan
TEL 06-6326-1121
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiyasu Nagato
Organization Iseikai Hospital
Division name Respiratory Disease Center
Zip code
Address
TEL 06-6326-1121(793)
Homepage URL
Email

Sponsor
Institute Iseikai Hospital
Institute
Department

Funding Source
Organization Iseikai Hospital
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 医誠会病院(大阪府)

Other administrative information
Date of disclosure of the study information
2011 Year 07 Month 31 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 Terminated
Date of protocol fixation
2011 Year 02 Month 14 Day
Date of IRB
Anticipated trial start date
2011 Year 08 Month 01 Day
Last follow-up date
2014 Year 08 Month 01 Day
Date of closure to data entry
2014 Year 08 Month 01 Day
Date trial data considered complete
2014 Year 08 Month 01 Day
Date analysis concluded
2014 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 07 Month 22 Day
Last modified on
2015 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007100

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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