UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006021 |
|---|---|
| Receipt number | 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 12:01:13 |
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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
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
Sponsor or person
Institute
Iseikai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007100
