UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025624
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email yryohei@asahiakwa-med.ac.jp

Sponsor
Institute Respiratory Center. Asahikawa Medical University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029483

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.