UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008027 |
|---|---|
| Receipt number | 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 09:32:00 |
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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
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
yamaguchi.m@nk-cc.go.jp
Sponsor or person
Institute
Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009450
