UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025278 |
|---|---|
| Receipt number | R000027819 |
| Scientific Title | An observational study of EGFR mutation status by circulating tumor DNA during the osimertinib treatment of lung cancer harboring EGFR activating and T790M mutations. |
| Date of disclosure of the study information | 2016/12/20 |
| Last modified on | 2021/08/05 22:48:06 |
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Basic information
Public title
An observational study of EGFR mutation status by circulating tumor DNA during the osimertinib treatment of lung cancer harboring EGFR activating and T790M mutations.
Acronym
An observational study of plasma EGFR mutation status during osimertinib treatment.
Scientific Title
An observational study of EGFR mutation status by circulating tumor DNA during the osimertinib treatment of lung cancer harboring EGFR activating and T790M mutations.
Scientific Title:Acronym
An observational study of plasma EGFR mutation status during osimertinib treatment.
Region
| Japan |
Condition
Condition
lung Cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clear the resistant mechanism of osimertinib treatment for lung cancer harboring EGFR activating and T790M mutations by periodical analysis of EGFR mutations (activating, T790M, and C797S) in circulating tumor DNA using an improved PNA-LNA PCR clamp method.
Basic objectives2
Others
Basic objectives -Others
To evaluate the percentage of the cases emerging C797S mutation in all oseimertinib resistant patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The occurrence ratio of plasma C797S mutations in all osimertinib resistant cases.
Key secondary outcomes
The interval between plasma C797S emerged time and the time of confirmed RECIST PD.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1. Histologically or cytologically documented non-small cell lung cancer.
2. Stage IIIB or stage IV or recurrent NSCLC
3. Detected EGFR activating mutation (exon 19 deletion or exon 21 L858R) by highly sensitive PCR methods.
4. Have a history of first or second generation EGFR-TKI treatment.
5. Detected T790M mutation by highly sensitive PCR methods.
6. Regarding the patients who have be treated with radiotherapy;
1) Not have received radiotherapy to lesions of lung.
2) More than 12 weeks after receiving radiotherapy to bone metastases in thoracic lesion.
3) More than 2 weeks after receiving radiotherapy to lesions except lung.
7. Regarding the patients who have be treated with therapy as follows;
1) More than 4 weeks after the last operation
2) More than 2 weeks after the last drainage of the pleural space.
3) More than 2 weeks after the last pleurodesis except anticancer drugs
4) More than 3 weeks after the last cytotoxic chemotherapy.
8. Patients who have at least one or more measurable lesion by RESIST (Version1.1)
9. Performance status (ECOG) 0-2
10. Estimated life expectancy at least 3 months.
11. Adequate organ function for osimertinib treatment
12. Written informed consent.
13. Aged over 20 years.
Key exclusion criteria
1. Having an evidence of ILD or pulmonary fibrosis complication on chest X-ray.
2. Having a history or serious complications as bellows:
1) uncontrollable angina pectoris, cardial infarction within 3 months before enrollment, or heart failure.
2) uncontrollable diabetes or hypertension.
3) Severe infectious disease..
4) gastrointestinal dysfunction with severe diarrhea.
3. Impossible to take drugs orally.
4. Inadequate case considered from drug package insert of osimertinib.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Maemondo |
Organization
Miyagi Cancer Center
Division name
Department of respiratory medicine
Zip code
Address
47-1 Nodayama, Medecshima-Shiote, Natori, Japan
TEL
022-384-3151
maemondo-ma693@miyagi-pho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuro Fukuhara |
Organization
Miyagi Cancer Center
Division name
Department of respiratory medicine
Zip code
Address
47-1 Nodayama, Medecshima-Shiote, Natori, Japan
TEL
022-384-3151
Homepage URL
fukuhara-tatsuro@miyagi-pho.jp
Sponsor or person
Institute
Miyagi Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Miyagi Cancer Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Division of Cancer Biology and Therapeutics, Miyagi Cancer Center Research Institute.
Molecular Genetic Research Department, LSI Medience Corporation.
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
| 2016 | Year | 12 | Month | 20 | 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
Main results already published
Date of protocol fixation
| 2016 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To clear the resistant mechanism of osimertinib treatment for lung cancer harboring EGFR activating and T790M mutations by periodical analysis of EGFR mutations (activating, T790M, and C797S) in circulating tumor DNA using an improved PNA-LNA PCR clamp method. Analysis points are before treatment, every 8 weeks from osimertinib started, and Confirmed RECIST-PD.
Management information
Registered date
| 2016 | Year | 12 | Month | 15 | Day |
Last modified on
| 2021 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027819
