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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025278
Receipt No. 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 2018/04/09

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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
Email 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
Email fukuhara-tatsuro@miyagi-pho.jp

Sponsor
Institute Miyagi Cancer Center
Institute
Department

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
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
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 Enrolling by invitation
Date of protocol fixation
2016 Year 09 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 05 Day
Last follow-up date
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
2018 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027819

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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