UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025624 |
|---|---|
| Receipt number | R000029483 |
| Scientific Title | Phase II study of EGFR-TKI in elderly patients with lung cancer harboring EGFR gene mutation in liquid biopsy |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2017/01/11 15:12:22 |
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Basic information
Public title
Phase II study of EGFR-TKI in elderly patients with lung cancer harboring EGFR gene mutation in liquid biopsy
Acronym
Phase II study of EGFR-TKI in elderly patients with lung cancer harboring EGFR gene mutation in liquid biopsy (ALCSG-03)
Scientific Title
Phase II study of EGFR-TKI in elderly patients with lung cancer harboring EGFR gene mutation in liquid biopsy
Scientific Title:Acronym
Phase II study of EGFR-TKI in elderly patients with lung cancer harboring EGFR gene mutation in liquid biopsy (ALCSG-03)
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy and safety of EGFR-TKI in elderly patients of lung cancer harboring EGFR gene mutation in liquid biopsy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate.
Key secondary outcomes
Safety, progression free survival, overall survival.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Single agent Erlotinib or Gefitinib
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligibility includes;
(1) Patients of lung cancer diagnosed with CT imaging by respiratory medicine specialist
(2) Patients harboring EGFR gene mutation Exon19 deletion or L858R in liquid biopsy with Cobas ver2.0.
(3) Clinical stage from IIIA toIV.
(4) Patients aged 70 and over 70 years.
(5) Patients who are not treated with EGFR-TKI previously.
(6) Patients who can take EGFR-TKI orally.
(7) Patients having adequate organ function.
(8) Letter of consent
Key exclusion criteria
Patients are excluded if they have;
(1) Severe concomitant disease.
(2) Severe history of hypersensitivity.
(3) Severe heart disease or arrhythmia.
(4) Interstitial pneumonia.
(5) Active infection.
(6) Active peptic ulcer.
(7) Active double cancer.
(8) No measurable lesion.
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Ohsaki |
Organization
Asahikawa Medical University Hospital
Division name
Respiratory Center
Zip code
Address
2-1-1-1 Midorigaoka-higashi, Asahikawa-shi, Hokkaido, 078-8510 Japan
TEL
0166-69-3290
yohsaki@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryohei Yoshida |
Organization
Asahikawa Medical University Hospital
Division name
Respiratory Center
Zip code
Address
2-1-1-1 Midorigaoka-higashi, Asahikawa-shi, Hokkaido, 078-8510 Japan
TEL
0166-69-3290
Homepage URL
yryohei@asahiakwa-med.ac.jp
Sponsor or person
Institute
Respiratory Center. Asahikawa Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Respiratory Center. Asahikawa Medical University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Asahikawa Lung Cancer Study Group(ALCSG)
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
| 2017 | Year | 02 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 01 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 11 | Day |
Last modified on
| 2017 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029483
| 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 |
