UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief 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.
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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Kenji Sugio
Organization	Oita University Faculty of Medicine
Division name	Department of Thoracic and Breast Surgery
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	Masafumi Yamaguchi
Organization	National Kyushu Cancer Center
Division name	Department of Thoracic Oncology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 12 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000009450