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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002789
Receipt No. R000003380
Scientific Title Randomized phase II study of continuous gefitinib plus chemotherapy versus alternation of gefitinib and chemotherapy in previously untreated non-small cell lung cancer (NSCLC) with sensitive EGFR mutations (NEJ005/TCOG0902)
Date of disclosure of the study information 2009/11/20
Last modified on 2017/05/31

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Basic information
Public title Randomized phase II study of continuous gefitinib plus chemotherapy versus alternation of gefitinib and chemotherapy in previously untreated non-small cell lung cancer (NSCLC) with sensitive EGFR mutations (NEJ005/TCOG0902)
Acronym Continuous gefitinib plus chemotherapy versus alternation of gefitinib and chemotherapy in NSCLC with EGFR mutations
Scientific Title Randomized phase II study of continuous gefitinib plus chemotherapy versus alternation of gefitinib and chemotherapy in previously untreated non-small cell lung cancer (NSCLC) with sensitive EGFR mutations (NEJ005/TCOG0902)
Scientific Title:Acronym Continuous gefitinib plus chemotherapy versus alternation of gefitinib and chemotherapy in NSCLC with EGFR mutations
Region
Japan

Condition
Condition Non-small cell lung cancer with EGFR mutations (non-squamous histology)
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety in combination of chemotherapy and gefitinib therapy in non-small cell lung cancer (NSCLC) harboring sensitive EGFR mutations by comparing continuous gefitinib plus chemotherapy with alternation of gefitinib and chemotherapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Progression-free survival
Key secondary outcomes Response rate, overall survival, and safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Continuous gefitinib plus chemotherapy (Carboplatin + Pemetrexed)
Interventions/Control_2 Alternation of gefitinib and chemotherapy (Carboplatin + Pemetrexed)
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) Histologically or cytologically proven NSCLC (non-squamous histology)
2) Stage IIIB, IV, or relapsed NSCLC
3) NSCLC harboring sensitive EGFR mutations
4) At least one measurable lesion
5) Chemotherapy-naive patients
6) Over 20 years old and under 75 years old
7) ECOG performance status of 0-1
8) Adequate organ functions (WBC >= 4,000 /mm3, Neutrophil >= 2,000 /mm3, Platelet >= 100,000 /mm3, Hemoglobin concentration >= 9.0 g/dl, AST or ALT <= twice the number of ULN, T-bilirubin <= 1.5 mg/dl, Cr <= 1.5 mg/dl, PaO2 or SpO2 >= 60 Torr or 95%)
9) Life expectancy of at least 3 months
10) Written informed consent
Key exclusion criteria 1) Presence of active interstitial pneumonia
2) Resistant T790M mutation
3) Unstable metastases to the brain
4) History of radiotherapy for primary lesion
5) Severe and uncontrolled complication
6) Severe gastroenterological and intestinal disease
7) Treatment with steroid for longer than 4 weeks
8) Uncontrolled pleural effusion or ascites
9) Pregnant patients
10) Gefitinib contraindication
11) Other active malignancies
12) Decision of ineligibility by a physician
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Oizumi
Organization National Hospital Organization Hokkaido Cancer Center
Division name Department of Respiratory Medicine
Zip code
Address 3-54 Kikusui 4-2 Shiroishi-ku, Sapporo 003-0804, Japan
TEL 011-811-9111
Email soizumi@sap-cc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Oizumi
Organization National Hospital Organization Hokkaido Cancer Center
Division name Department of Respiratory Medicine
Zip code
Address 3-54 Kikusui 4-2 Shiroishi-ku, Sapporo 003-0804, Japan
TEL 011-811-9111
Homepage URL
Email soizumi@sap-cc.go.jp

Sponsor
Institute North East Japan Study Group/The Tokyo
Cooperative Oncology Group
Institute
Department

Funding Source
Organization None
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

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 20 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/25669832
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
2009 Year 11 Month 04 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
2017 Year 04 Month 30 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 11 Month 20 Day
Last modified on
2017 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003380

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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