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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003274
Receipt No. R000003960
Scientific Title A phase II trial of gefitinib and concurrent radiation therapy for locally advanced non-small cell lung cancer patients harboring sensitive EGFR mutations.
Date of disclosure of the study information 2010/03/01
Last modified on 2011/09/02

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Basic information
Public title A phase II trial of gefitinib and concurrent radiation therapy for locally advanced non-small cell lung cancer patients harboring sensitive EGFR mutations.
Acronym A phase II trial of gefitinib and concurrent radiation therapy for locally advanced non-small cell lung cancer patients harboring sensitive EGFR mutations.
Scientific Title A phase II trial of gefitinib and concurrent radiation therapy for locally advanced non-small cell lung cancer patients harboring sensitive EGFR mutations.
Scientific Title:Acronym A phase II trial of gefitinib and concurrent radiation therapy for locally advanced non-small cell lung cancer patients harboring sensitive EGFR mutations.
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To assess the safety and efficacy of gefitinib and concurrent radiation therapy for locally advanced non-small cell lung cancer patients harboring sensitive EGFR mutations.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Safety
Key secondary outcomes Adverse event rates,Response rate,Disease control rate, Progression free survival, Two-year survival rate

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 gefitinib with concurrent radiation therapy
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.Unresectable locally advanced NSCLC
2.Histologically or cytologically confirmed NSCLC
3.Patients harboring EGFR mutations (exon 19 deletion or L858R)
4.No prior medication (chemotherapy, radiation therapy or surgery) and stage IIIA or IIIB.
5.ECOG performance status (PS): 0-1
6. V20 <= 35%
7.Patients aged 20 years old or older
8.Adequate organ function.
WBC count >= 4,000/mm3,
Neutrophil count >= 2,000/mm3
Platelet count >= 100,000/mm3
hemoglobin >= 9.5g/dL
AST and ALT <= 100 IU/L
Bilirubine level <= 1.5 mg/dL
Serum creatinine <= 1.2 mg/dL
PaO2 >= 70 torr
9.Patients who are considered to survive for more than 3 months
10.Written informed consent
Key exclusion criteria 1.Patients with active severe infections
2.Significant interstitial pneumonitis
, pulmonary fibrosis on Chest CT
3.Contralateral hilar lymph node metastasis
4.Patietns with ileus
5.Patients with uncontrollable diarrhea
6.The presence of other concomitant cancers
7.Serious allergy history
8.Patients with total gastrectomy
9.Heavy smoking habit: (the number of cigarettes smoked daily) x (smoking period)> 400
10.Tumor infiltrating great vessels clearly
11.Patients harboring T790M mutation
12.Inappropriate patients for this study judged by the physicians

Target sample size 15

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 Clinical reserch center
Zip code
Address 1180 Nagasone-cho, Kita-ku, Sakai-city, Osaka591-8555 JAPAN
TEL 072-252-3021
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Asami
Organization National Hospital Organization Kinki-chuo Chest Medical Center
Division name Medical oncology
Zip code
Address 1180 Nagasone, Kitaku, Sakai, Osaka, Japan
TEL 072-252-3021
Homepage URL
Email

Sponsor
Institute National Hospital Organization
Institute
Department

Funding Source
Organization National Hospital Organization Headquarters Center
Organization
Division
Category of Funding Organization
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 独立行政法人国立病院機構 国立病院、国立医療センター

Other administrative information
Date of disclosure of the study information
2010 Year 03 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 No longer recruiting
Date of protocol fixation
2010 Year 03 Month 07 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
2014 Year 03 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
2010 Year 03 Month 01 Day
Last modified on
2011 Year 09 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003960

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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