UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002789 |
|---|---|
| Receipt number | 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 | 2021/08/23 14:03:39 |
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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 | Satoshi |
| Middle name | |
| Last name | Oizumi |
Organization
National Hospital Organization Hokkaido Cancer Center
Division name
Department of Respiratory Medicine
Zip code
003-0804
Address
3-54 Kikusui 4-2 Shiroishi-ku, Sapporo 003-0804, Japan
TEL
011-811-9111
soizumi@hokkaido.med.or.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Oizumi |
Organization
National Hospital Organization Hokkaido Cancer Center
Division name
Department of Respiratory Medicine
Zip code
003-0804
Address
3-54 Kikusui 4-2 Shiroishi-ku, Sapporo 003-0804, Japan
TEL
011-811-9111
Homepage URL
soizumi@hokkaido.med.or.jp
Sponsor or person
Institute
North East Japan Study Group/The Tokyo
Cooperative Oncology Group
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics review boards, Hokkaido Cancer Center
Address
3-54 Kikusui 4-2 Shiroishi-ku, Sapporo 003-0804, Japan
Tel
011-811-9111
soizumi@hokkaido.med.or.jp
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
Main results already published
Date of protocol fixation
| 2009 | Year | 11 | Month | 04 | Day |
Date of IRB
| 2009 | Year | 11 | Month | 04 | Day |
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
| 2021 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003380
