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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008027
Receipt No. R000009450
Scientific Title Multicenter phase II trial of continuous EGFR-TKIs for elderly patients with EGFR sensitive mutation who failed the first EGFR-TKIs treatment for advanced non-small cell lung cancer.
Date of disclosure of the study information 2012/05/28
Last modified on 2016/05/25

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Basic information
Public title Multicenter phase II trial of continuous EGFR-TKIs for elderly patients with EGFR sensitive mutation who failed the first EGFR-TKIs treatment for advanced non-small cell lung cancer.
Acronym Multicenter phase II trial of continuous EGFR-TKIs for elderly patients with EGFR sensitive mutation who failed the first EGFR-TKIs treatment for advanced non-small cell lung cancer.
Scientific Title Multicenter phase II trial of continuous EGFR-TKIs for elderly patients with EGFR sensitive mutation who failed the first EGFR-TKIs treatment for advanced non-small cell lung cancer.
Scientific Title:Acronym Multicenter phase II trial of continuous EGFR-TKIs for elderly patients with EGFR sensitive mutation who failed the first EGFR-TKIs treatment for advanced non-small cell lung cancer.
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy and safety of continuous gefitinib with second line chemotherapy for elderly patients with EGFR sensitive mutation who failed the first gefitinib treatment for advanced non-small cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes progression free survival
Key secondary outcomes disease control rate on 6th, 12th and 18th treatment week, overall survival, adverse effect

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 YES
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A:Reference arm
Chemotherapy
Interventions/Control_2 B:Experimental arm
Chemotherapy plus EGFR-TKIs continuation
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
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Pathologically or cytologically confirmed non-small cell lung cancer.
2. Patients without previous EGFR-TKIs (gefitinib, erlotinib or afatinib) treatment for non-small cell lung cancer.
3. Patients with clinical stage IIIB unsuitable for radiotherapy or Stage IV.
4. Patients who have confirmed EGFR mutation of exon 19 deletion or Exon 21 mutation.
5. Patients have previously treated with EGFR-TKIs (gefitinib, erlotinib or afatinib) as 1st-line chemotherapy, and have a disease control at least 8weeks. Registration within 42 days after the day of disease progression confirmation.
6. Patients with tolerable adverse effect during EGFR-TKIs (gefitinib, erlotinib or afatinib) treatment
7. Age 70 year-old and over.
8. Patients with evaluable disease defined by RECIST.
9. ECOG performance status 0-2.
10. Sufficient organ function
Hb >=9.0 g/dL
WBC >=2000/mm3
Plt >=100000/mm3
GOT/GPT <=100IU/L
Cr =<1.5mg/dL
SpO2>=92%
11. Written informed consent.
Key exclusion criteria 1. Patients with difficulty of oral dosing continuation for 250mg gefitinib more than once in three days, more than 50 mg erlotinib every day or more than 100mg erlotinib every other day, or more than 20 mg afatinib every day.
2. Patients with active infection or uncontrollable disease.
3. Patients with clinically pulmonary disorders such as idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia or radioactive pneumonitis on chest CT.
4. Patients with induction or adjuvant chemotherapy within 12 months.
5. Patients with massive pleural effusion, ascites, pericardial effusion or SVC syndrome (drainage or pleurodesis with OK432 or bleomycin are permissive.)
6. Patients with symptomatic brain metastases or with treatment needs for steroids, anticonvulsant, etc.
7. Patients with severe drug allergy.
8. Patients with grade 3 or more diarrhea.
9. History of radiation therapy for mediastinum or lung.
10. History of active double cancer within 2 years.
11. Patients with hypersensitivity history or its suspicion to gefitinib, erlotinib and afatinib.
12. HBs antigen positive.
13. Patients who have possibility of pregnancy.
14. Patients whose participation in the trial is judged to be inappropriate by the attending doctor.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Sugio
Organization Oita University Faculty of Medicine
Division name Department of Thoracic and Breast Surgery
Zip code
Address 1-1, Idaigaoka, Hasama-machi, Yufu City, Oita, 879-5593, Japan
TEL 097-586-5854
Email ksugio@oita-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masafumi Yamaguchi
Organization National Kyushu Cancer Center
Division name Department of Thoracic Oncology
Zip code
Address 3-1-1, Notame, Minamiku, Fukuoka City, 811-1395, Japan
TEL 092-541-3231
Homepage URL
Email yamaguchi.m@nk-cc.go.jp

Sponsor
Institute Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department

Funding Source
Organization Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization JAPAN

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 飯塚病院(福岡県)
JCHO九州病院(福岡県)
九州大学(福岡県)
久留米大学(福岡県)
国立病院機構大牟田病院(福岡県)
国立病院機構九州医療センター(福岡県)
国立病院機構九州がんセンター(福岡県)
国立病院機構福岡東医療センター(福岡県)
浜の町病院(福岡県)
福岡大学(福岡県)
福岡大学 筑紫病院(福岡県)
福岡赤十字病院(福岡県)
佐賀県医療センター好生館(佐賀県)
佐賀大学(佐賀県)
長崎大学(長崎県)
日本赤十字社 長崎原爆病院(長崎県)
熊本大学(熊本県)
大分県立病院(大分県)
大分大学(大分県)
新別府病院(大分県)
川内市医師会立市民病院(鹿児島県)
沖縄県立南部医療センター・こども医療センター(沖縄県)
琉球大学(沖縄県)

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 28 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 Completed
Date of protocol fixation
2011 Year 12 Month 03 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 05 Month 25 Day
Last modified on
2016 Year 05 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009450

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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