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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033006
Receipt No. R000037620
Scientific Title Investigational study for the management of central nervous system metastasis in non-small-cell lung cancer
Date of disclosure of the study information 2018/07/01
Last modified on 2018/06/15

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Basic information
Public title Investigational study for the management of central nervous system metastasis in non-small-cell lung cancer
Acronym Investigational study for CNS metastasis management in NSCLC
Scientific Title Investigational study for the management of central nervous system metastasis in non-small-cell lung cancer
Scientific Title:Acronym Investigational study for CNS metastasis management in NSCLC
Region
Japan

Condition
Condition Non-small-cell lung cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Early detection of genomic alterations as well as various low frequency alleles in cerebrospinal fluid (CSF). It might contribute to investigate pathophysiology of central nervous system (CNS) metastasis in Non-small-cell lung cancer (NSCLC).
Basic objectives2 Others
Basic objectives -Others To figure out the mechanism of resistance of CNS metastasis against osimertinib.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes To figure out the mechanism of resistance of CNS metastasis against osimertinib.
Key secondary outcomes 1. Establishment of detection assays of cell-free DNA (cfDNA) in CSF.
2. Estimation of penetration property of osimertinib by serial quantification of osimertinib concentration in plasma as well as CSF.
3. Elucidation of sequential interaction among cfDNA in plasma/CSF, circulating tumor cells, and alteration of osimertinib concentration.

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 Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Oral osimertinib administration at a dose of 80 mg once daily, and plasma and CSF collections are planned at baseline before osimertinib treatment), 4months (
after osimertinib administration), progressive disease.
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 A. Assay establishing phase
1. Patients who do not have any previous histories of NSCLC and who are planned lumber puncture for clinical purpose.
2. Patients who provides written informed consent.

B. NSCLC patient sample collection phase
1. Patients with pathologically or cytologically confirmed NSCLC, who are planned osimertinib treatment.
2. Patients who have CNS metastasis.
3. Patients who do not need urgent treatment to improve symptoms such as surgery or radiation therapy to CNS metastasis.
4. Patients who have normal blood coagulation and platelet count should be over 100,000/mm3. Anticoagulants should be withheld for appropriate periods.
5. Performance status should be 0-2, and at least 12 week survival time should be expected.
6. Patients should be 20 years old or over.
7. Patients who understand the contents of this study and provide a written informed consent form.

Key exclusion criteria B. NSCLC patient sample collection phase
1. Patients who have been treated with following treatments. Cytotoxic chemotherapy within 14 days prior to osimertinib administration. The third generation EGFR-TKIs.
2. Patients who have any symptoms due to high intracranial pressure.
3. Patients who need urgent treatment such as surgery or radiation therapy to CNS metastasis.
4. Patients who have obvious infection at lumber puncture site.
5. Patients who have interstitial lung disease.
6. Patients who have uncontrolled systematic disease.
7. Patients who have difficulties in taking osimertinib tablets, or who have previous history of stomach or bowel surgeries which might affect drug absorption.
8. Patients who have hypersensitivity to osimertinib.
9. Patients who have previous history of malignant diseases.
10. Patients who have abnormal blood coagulation and whose platelet count is less than 100,000/mm3.
11. Patients who want to withdraw from this study.
12. Patients who cannot understand the contents of this study and cannot give their consent.
13. Patients who cannot follow the protocol contents of this study, or patients who are inappropriate for this study.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nahomi Tokudome
Organization Wakayama Medical University
Division name Respiratory Medicine/ Medical Oncology
Zip code
Address 811-1, Kimiidera, Wakayama-city, 641-0012 Japan
TEL 073-441-0619
Email ntokudom@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nahomi Tokudome
Organization Wakayama Medical University
Division name Respiratory Medicine/ Medical Oncology
Zip code
Address 811-1, Kimiidera, Wakayama-city, 641-0012 Japan
TEL 073-441-0619
Homepage URL
Email ntokudom@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Respiratory Medicine/ Medical Oncology
Institute
Department

Funding Source
Organization Wakayama Medical University
Respiratory Medicine/ Medical Oncology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2018 Year 07 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 Preinitiation
Date of protocol fixation
2018 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 15 Day
Last modified on
2018 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037620

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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