UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	PhaseIII study of gefitinib versus cisplatin plus docetaxel in patients with non-small cell lung cancer with EGFR mutation
Title of the study (Brief title)	WJTOG3405
Region	Japan

Condition
Condition	non small cell lung cancer
Classification by specialty	Hematology and clinical oncology Chest surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To compare progression free survival of patients with non-small cell lung cancer harboring EGFR gene mutations (exon 19 deletion or L858R) treated with gefitinib monotherapy with those treated with CDDP plus docetaxel
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Progression free survival
Key secondary outcomes	Overall survival Response

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Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	A: Experimental arm Gefitinib (250mg/day) monotherapy until disease progression
Interventions/Control_2	B: Reference arm CDDP (80mg/sqm) day1, Docetaxel (60mg/sqm), q3w x 3-6 courses
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	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1.A) Patients with NSCLC who have recurrent disease after surgery with no prior drug therapy for the recurrent disease and who are not candidates for radiotherapy with a curative intent. Those who received postoperative adjuvant chemotherapy other than CDDP+DOC are eligible. OR B) NSCLC patients with stage IIIB or IV disease with no prior treatment who are not candidates for surgical resection or radiotherapy with a curative intent. 2.A case with confirmed EGF-R genomic mutation (deletion in Exon 19 or codon 858 change of Leucin to Arginine in Exon 21) in the histologic or cytologic specimen in which tumor cells definitely exist. 3.A case of which histologic or cytologic (pleural effusion) specimen is reserved if the case needs to be pre-registered because of no confirmation of EGF-R mutation. 4.Patients with evaluable disease (not necessarily to be measurable by RECIST) 5. If the patient underwent pre- or postoperative chemotherapy, there should be the following interval between the chemotherapy and the registration. i) Platinum doublet ->6 months ii) other (UFT and other fluoropyrimmidine, non-platnum) -> 1 month 6. If the patient underwent radiotherapy, there should be the following interval between the radiotherapy and the registration. i)Radiotherapy including pulmonary field ->3 months ii)Radiotherapy other than thoracic radiation ->1 month 7. Age eligible for study: 20 years and above, 75 years and below 8. ECOG PS 0-1 9. Sufficient organ function 10. Written informed consent
Key exclusion criteria	1. Prior drug therapy targeting EGFR (TKI, Abs) 2. History of interstitial pneumonia or pulmonary fibrosis (Patients with radiation pneumonitis limited to radiation field are eligible) 3. History of severe drug allergy 4. History of active infection or other serious disease condition (GI bleeding, poorly controlled cardiac diseases, cirrhosis, ileus, persistant watery diarrhea, etc.) 5. History of symptomatic brain metastases. Brain metastases necessitating drug therapy for brain edema 6. History of poorly controlled pleural effusion 7. History of pericardial effusion or ascites necessitating drainage 8. History of active double cancer 9. History of severe hypersensitivity to polysolvate 80 containing drugs 10. History of pregnancy or lactation 11. Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size	200

Research contact person
Name of lead principal investigator	Tetsuya Mitsudomi
Organization	Kinki University Faculty of Medicine
Division name	Division of Thoracic Surgery, Department of Surgery
Address	377-2 Ohno-Higashi, Osaka-Sayama, Japan
TEL	072-366-0221
Email	mitsudom@surg.med.kindai.ac.jp

Public contact
Name of contact person	Shinichiro Nakamura
Organization	West Japan Oncology Group
Division name	WJOG datacenter
Address	Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
TEL	06-6633-7400
Homepage URL
Email	datacenter@wjog.jp

Sponsor
Institute	West Japan Oncology Group
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	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2006 Year 12 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2006 Year 01 Month 26 Day
Anticipated trial start date	2006 Year 03 Month 01 Day
Last follow-up date	2011 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.ncbi.nlm.nih.gov/pubmed/20022809
Results
Other related information

Management information
Registered date	2006 Year 12 Month 06 Day
Last modified on	2016 Year 04 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000656