UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016391 |
|---|---|
| Receipt number | R000019038 |
| Scientific Title | Phase II study of gefitinib combined with carboplatin/pemetrexed for elderly patients with EGFR mutated advanced non-small cell lung cancer |
| Date of disclosure of the study information | 2015/01/30 |
| Last modified on | 2019/08/03 15:46:10 |
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Basic information
Public title
Phase II study of gefitinib combined with carboplatin/pemetrexed for elderly patients with EGFR mutated advanced non-small cell lung cancer
Acronym
Gefitinib plus chemotherapy for elderly patient with EGFR-mutated NSCLC
Scientific Title
Phase II study of gefitinib combined with carboplatin/pemetrexed for elderly patients with EGFR mutated advanced non-small cell lung cancer
Scientific Title:Acronym
Gefitinib plus chemotherapy for elderly patient with EGFR-mutated NSCLC
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety for elderly patients treated with gefitinib plus carboplatin/pemetrexed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression Free Survival (PFS)
Key secondary outcomes
Objective Response Rate, Disease Control Rate, Adverse Events, Overall Survival, QOL
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
Patients receive oral gefitinib 250mg once daily and carboplatin(AUC=5)/ pemetrexed(500mg/m2) on day1 every 3 weeks.
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically or cytologically confirmed non-small cell lung cancer.
2) Clinical Stage IIIB which curative radiotherapy is not indicated, IV or postoperative recurrence
3) EGFR mutation positive
4) At least one measurable lesion
5) No prior chemotherapy treatment
6) Age of 75 years or older
7) ECOG Performance status of 0-1
8) Sufficient major organ function
9) Life expectancy of at least 3 months
10) Written informed consent
Key exclusion criteria
1) Radiographically confirmed interstitial pneumonitis or pulmonary fibrosis.
2) NSCLC harboring T790M mutation
3) No prior gefitinib or pemetrexed treatment as ajuvant/neoajuvant therapy.
4) Symptomatic brain metastases
5) Radiation therapy for primary site.
6) Severe concurrent disease
7) HBs antigen or HBc antibody or HBs antibody positive
8) Patient are treated with steroid continuously
9) Pleural and peritoneal effusion likely to require surgical intervention, or pericardial effusion
10) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy.
11) Active double cancer
12) Physician concludes that the patient's participation in this trial is inappropriate.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Inoue |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Palliative Medicine
Zip code
Address
1-2, Seiryocho, Aobaku, Sendai
TEL
+81-22-717-7366
akira.inoue.b2@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eisaku Miyauchi |
Organization
Tohoku University Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
1-1, Seiryocho, Aobaku, Sendai
TEL
+81-22-717-8539
Homepage URL
miyauchi@rm.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
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
| 2015 | Year | 01 | Month | 30 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 30 | Day |
Last modified on
| 2019 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019038
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| Registered date | File name |
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| Registered date | File name |
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