UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005086 |
|---|---|
| Receipt number | R000006047 |
| Scientific Title | Phase II trial of induction gefitinib followed by cisplatin and docetaxel with concurrent radiotherapy in locally advanced non-small cell lung cancer with EGFR activating mutation |
| Date of disclosure of the study information | 2011/02/15 |
| Last modified on | 2022/04/08 15:26:50 |
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Basic information
Public title
Phase II trial of induction gefitinib followed by cisplatin and docetaxel with concurrent radiotherapy in locally advanced non-small cell lung cancer with EGFR activating mutation
Acronym
Phase II trial of induction gefitinib followed by cisplatin and docetaxel with concurrent radiotherapy in locally advanced non-small cell lung cancer with EGFR activating mutation
Scientific Title
Phase II trial of induction gefitinib followed by cisplatin and docetaxel with concurrent radiotherapy in locally advanced non-small cell lung cancer with EGFR activating mutation
Scientific Title:Acronym
Phase II trial of induction gefitinib followed by cisplatin and docetaxel with concurrent radiotherapy in locally advanced non-small cell lung cancer with EGFR activating mutation
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Step 1: confirmation of safety of induction gefitinib followed by cisplatin and docetaxel with concurrent thoracic radiotherapy in loclly advanced non-small cell lung cancer with EGFR mutation
Step 2: evaluation of efficacy and safety of induction gefitinib followed by cisplatin and docetaxel with concurrent thoracic radiotherapy in loclly advanced non-small cell lung cancer with EGFR mutation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Two year survival rate
Key secondary outcomes
Survival time, progression free survival time, five year survival rate, completion rate of protocol therapy, response rate of induction therapy, response rate of chemoradiation, site and type of progression, incidence of adverse events, correlation between radiation field and survival, correlation between protein expression of molecular marker; ERCC1, RRM1, BRCA1, TSP1, TXR1, thioredoxin, and efficacy or safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Induction therapy with gefitinib
Cisplatin and docetaxel with concurrent thoracic radiotherapy
Interventions/Control_2
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) Non small-cell lung cancer proven cytologically or histologically
2) Patients having EGFR mutation (exon 19 deletion or L858R)
3) treatment naive c-stage IIIA or IIIB
4) Patient who has measurable lesion by RECIST.
5) V20 in radiation field <= 35%
6) oral intake possible
7) Performance status (ECOG)0-2.
8) age 20-74 years old
9) adequate organ functions(within 2 weeks before registration)
1. WBC >= 3,500/mm3
2. Neu >= 2,000/ mm3
3. Plt >= 100,000/ mm3
4. Hb >= 9.0g/dl
5. AST and ALT, x 2 of upper limit of normal (ULN) or less
6. T-Bil < 1.5mg/dl
7. Serum creatinin, x 1.5 of ULN or less
creatinine clearance>=60ml/min
8. SpO2 or blood gas SpO2 >= 90% or PaO2 >= 60 torr
9. Lung function 1 second amount More than 1.5L
10) Written informed consent
Key exclusion criteria
1) Patients having EGFR gene mutation (T790M)
2) Past history of drug hypersensitivity
3) Patients with superior vena cava (SVC) syndrome
4) pulmonary fibrosis or interstitial pneumonitis evident on chest CT
5) serious heart dosease
6) Psychiatric disorder
7) uncontrollable diabetes
8) paresis of intestine, intestinal obstruction
9) Patients with active severe infections
10) serious complications other
11) Patients with active concomitant malignancy
12) Pregnant or lactation women, or women with known or suspected pregnancy
13) Inappropriate to entry by physician
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | Katsuyuki |
| Middle name | |
| Last name | Hotta |
Organization
Okayama University Hospital
Division name
Center for Innovative Clinical Medicine
Zip code
700-8558
Address
2-5-1 Shikata-cho,kita-ku, Okayama
TEL
086-223-7151
khotta@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Saeki |
Organization
Kumamoto University hospital
Division name
Department of Respiratory Medicine
Zip code
860-8556
Address
1-1-1 Honjo, Kumamoto-city,Kumamoto,860-8556,Japan
TEL
096-373-5012
Homepage URL
saeshow@wg7.so-net.ne.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
Okayama Lung Cancer Study Group (OLCSG)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Network Fukuoka Certified Review Board
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Fukuoka
Tel
092-643-7171
mail@crnfukuoka.jp
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
北九州市立医療センター（福岡県）
九州大学病院（福岡県）
国立病院機構九州がんセンター（福岡県）
熊本大学病院（熊本県）
岡山大学病院（岡山県）
中国中央病院（広島県）
四国がんセンター（愛媛県）
愛媛県立中央病院（愛媛県）
日本赤十字社岡山赤十字病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 15 | Day |
Related information
URL releasing protocol
http://www.logik.jp/
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
Main results already published
Date of protocol fixation
| 2010 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2011 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 15 | Day |
Last modified on
| 2022 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006047
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
