UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000539 |
|---|---|
| Receipt number | 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 09:39:01 |
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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
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
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000656
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