UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003808 |
|---|---|
| Receipt number | R000004532 |
| Scientific Title | A Phase II Study of Pemetrexed and Gefitinib in Chemotherapy Naive Patients with Non-Small Cell Lung Cancer Harboring Mutations of EGFR |
| Date of disclosure of the study information | 2010/06/24 |
| Last modified on | 2015/06/23 15:20:19 |
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Basic information
Public title
A Phase II Study of Pemetrexed and Gefitinib in Chemotherapy Naive Patients with Non-Small Cell Lung Cancer Harboring Mutations of EGFR
Acronym
Pemetrexed and Gefitinib in Chemotherapy Naive Patients with NSCLC
Scientific Title
A Phase II Study of Pemetrexed and Gefitinib in Chemotherapy Naive Patients with Non-Small Cell Lung Cancer Harboring Mutations of EGFR
Scientific Title:Acronym
Pemetrexed and Gefitinib in Chemotherapy Naive Patients with NSCLC
Region
| Japan |
Condition
Condition
Non-Small Cell Lung Cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of Pemetrexed and Gefitinib in chemotherapy naive patients with NSCLC harboring mutations of EGFR
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
RR:response rate
Key secondary outcomes
PFS: progression free survival
OS: overall survival
DCR: disease control rate
AEs: adverse events
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
1.Pemetrexed(500mg/m2) Day1 q3weeks
Supplementation with folic acid and vitamin B12
2. Gefitinib(250mg) Day2-16 q3weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically or cytologically proven non-squamous, non-small cell lung cancer.
2)NSCLC harboring mutations of EGFR.
3) Stage III, IV
4) Chemothrapy naive patients
5) Performance Status(ECOG Scale): 0-1.
6) Adequate organ function
7) Life expectancy more than 12 weeks.
8) Written informed consent.
Key exclusion criteria
1) Using NSAIDs regularly.
2) Interstitial pneumonia/lung fibrosis on chest CT.
3) Previous drug allergy
4) History of poorly controlled pleural effusion, pericardial effusion and ascites.
5) Active infection.
6) Current Diarrhea.
7) Ileus or intestinal tract paralysis.
8) Symptomatic brain metastasis.
9) Active concomitant malignancy.
10) History of sever heart disease.
11) History of sever psychological disease.
12) Hoped to be pregnant/nursing.
13) Those judged to be not suitable by the attending physician.
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinzoh Kudoh |
Organization
Graduate School of Medicine, Osaka City University
Division name
Department of Respiratory Medicine
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3793
y-naruo@sc4.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naruo Yoshimura |
Organization
Graduate School of Medicine, Osaka City University
Division name
Department of Respiratory Medicine
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3793
Homepage URL
y-naruo@sc4.so-net.ne.jp
Sponsor or person
Institute
Osaka Lung Cancer Study 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
大阪市立大学医学部附属病院（大阪府）、大阪市立大学医学部附属病院（大阪府）、石切生喜病院（大阪府）、淀川キリスト教病院（大阪府）、ベルランド病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | Month | 24 | Day |
Related information
URL releasing protocol
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
Completed
Date of protocol fixation
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 23 | Day |
Last modified on
| 2015 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004532
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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