UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033006 |
|---|---|
| Receipt number | 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 14:08:25 |
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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
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
ntokudom@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Respiratory Medicine/ Medical Oncology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037620
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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