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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000539
Receipt No. R000000656
Scientific Title PhaseIII study of gefitinib versus cisplatin plus docetaxel in patients with non-small cell lung cancer with EGFR mutation
Date of disclosure of the study information 2006/12/11
Last modified on 2016/04/20

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Basic information
Public title PhaseIII study of gefitinib versus cisplatin plus docetaxel in patients with non-small cell lung cancer with EGFR mutation
Acronym WJTOG3405
Scientific Title PhaseIII study of gefitinib versus cisplatin plus docetaxel in patients with non-small cell lung cancer with EGFR mutation
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Tetsuya Mitsudomi
Organization Kinki University Faculty of Medicine
Division name Division of Thoracic Surgery, Department of Surgery
Zip code
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
1st name
Middle name
Last name Shinichiro Nakamura
Organization West Japan Oncology Group
Division name WJOG datacenter
Zip code
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

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
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

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/20022809
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
2006 Year 01 Month 26 Day
Date of IRB
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

Other
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

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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