UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015414 |
|---|---|
| Receipt number | R000017924 |
| Scientific Title | Exploratory clinical study of first-line treatment for patients with advanced EGFR mutation-positive non-squamous non-small-cell lung cancer |
| Date of disclosure of the study information | 2014/10/11 |
| Last modified on | 2018/04/16 12:55:44 |
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Basic information
Public title
Exploratory clinical study of first-line treatment for patients with advanced EGFR mutation-positive non-squamous non-small-cell lung cancer
Acronym
Exploratory clinical study of first-line treatment for patients with advanced EGFR mutation-positive non-squamous non-small-cell lung cancer
Scientific Title
Exploratory clinical study of first-line treatment for patients with advanced EGFR mutation-positive non-squamous non-small-cell lung cancer
Scientific Title:Acronym
Exploratory clinical study of first-line treatment for patients with advanced EGFR mutation-positive non-squamous non-small-cell lung cancer
Region
| Japan |
Condition
Condition
advanced EGFR mutation-positive non-squamous non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Prior to the initiation of treatment for advanced or postoperative recurrence EGFR mutation-positive non-squamous non-small cell lung cancer, we ask questions on the treatment to the patients. We select the treatment that the patient desires, to assess the efficacy and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
Overall survival, Response rate, Adverse events, QOL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
EGFR-TKI monotherapy (gefitinib, erlotinib or afatinib)
Interventions/Control_2
maintenance therpy of gefitinib plus pemetrexed after gefitinib, carboplatin plus pemetrexed concurrent therapy
Interventions/Control_3
erlotinib plus bevacizumab therapy involving the insertion of the bevacizumab, cisplatin plus pemetrexed combination therapy
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.Cytologically or histologically documented non-squamous non-small cell lung cancer
2.EGFR activating mutation positive
3.Stage III without any indications for radiotherapy, Stage IV, or postoperative recurrence
4.chemotherapy naive
5.Prior palliative radiotherapy
1)Except to the primary pulmonary lesion
2)more than two weeks after palliative radiotherapy for bone metastasis
6.Evaluable lesions (Measuarable lesions are not necessary)
7.20 years of age or older at the time of consent
8.ECOG PS 0-1
9.Have adequate organ function within two weeks before study entry
10.Have signed an informed consent
11.Estimated life expectancy of at least 3 months
Key exclusion criteria
1.EGFR mutation Exon20 T790M positive
2.Symptomatic brain metastasis and a spinal metastases requiring surgical treatment or irradiation
3.Less than 5 years of disease-free interval with other malignancy
4.Pleural effusion, ascites or pericardial fluid in need of treatment
5.SVC syndrome
6.Spinal cord compression with symptoms
7.Cerebrovascular disorder with aymptoms
8.Unhealed fracture
9.Severe infection
10.Planned surgery during the study period
11.Obvious interstitial lung disease
12.Severe gastrointestinal disorder
13.Symptomatic corneal disease
14.Severe cardiac disease
15.Clinically significant drug allergy
16.Prior EGFR-TKI therapy
17.During pregnabcy or lactating woman
18.Uncontrolled psychiatric disease
19.Other
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumio Imamura |
Organization
Osaka Medical Center for Cardiovascular diseases
Division name
Department of Thoracic Oncology
Zip code
Address
1-3-3 Nakamichi Higashinari-ku, Osaka
TEL
06-6972-1181
imamura-fu@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazumi Nishino |
Organization
Osaka Medical Center for Cardiovascular diseases
Division name
Department of Thoracic Oncology
Zip code
Address
1-3-3 Nakamichi Higashinari-ku, Osaka
TEL
06-6972-1181
Homepage URL
nisino-ka@mc.pref.osaka.jp
Sponsor or person
Institute
Department of Thoracic Oncology
Osaka Medical Center for Cardiovascular diseases
Institute
Department
Personal name
Funding Source
Organization
no
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
大阪府立成人病センター(大阪府）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 11 | 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 | 10 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 19 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 19 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 19 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 19 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 11 | Day |
Last modified on
| 2018 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017924
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