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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000005754
Receipt No. R000006802
Scientific Title Serum marker analysis of Erlotinib treatment in previously treated Non-small cell lung cancer (NSCLC) patients with and without Epidermal Growth Factor Receptor (EGFR) mutation (additional study of CJLSG0903/0904)
Date of disclosure of the study information 2011/06/16
Last modified on 2018/12/17

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Basic information
Public title Serum marker analysis of Erlotinib treatment in previously treated Non-small cell lung cancer (NSCLC) patients with and without Epidermal Growth Factor Receptor (EGFR) mutation (additional study of CJLSG0903/0904)
Acronym Serum marker analysis of Erlotinib treatment in previously treated NSCLC patients with and without EGFR mutation
Scientific Title Serum marker analysis of Erlotinib treatment in previously treated Non-small cell lung cancer (NSCLC) patients with and without Epidermal Growth Factor Receptor (EGFR) mutation (additional study of CJLSG0903/0904)
Scientific Title:Acronym Serum marker analysis of Erlotinib treatment in previously treated NSCLC patients with and without EGFR mutation
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To investigate the correlation between the serum marker analysis and the efficacy of Erlotinib treatment for previously treated NSCLC patients with and without EGFR Mutation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To investigate the correlation between the serum marker analysis and the clinical data such as response rate, disease control rate, overall survival and progression free survival for previously treated NSCLC patients with and without EGFR Mutation.
Key secondary outcomes To acquire the additional information on possible correlation between serum marker analysis and EGFR mutation status in previously treated NSCLC patients.

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) Patients with pathologically proven non-small cell lung cancer.
2) Patients who are not candidates for curative radiotherapy.
3) Patients with EGFR wild type or EGFR mutation (exon 19 deletion or exon 21 L858R) *Gene analysis by PNA-LNA PCR clamp method
4) No prior treatment with medicine concerning HER(gefitinib, trastuzumab, lapatinib, cetuximab,etc.).
5) Patients who have previously treated one or two chemotherapy(prior chemotherapy consisting of platinum agents in at least one regimen).
6) Patient who has at least one or more measurable lesion by RECIST.
7) ECOG performance status (PS): 0-2
8) Patients who can be hospitalized for four weeks after beginning of the treatment or under management to apply to it.
9) Patients aged 20 years or older.
10) Adequate organ function.
11) Patients who are considered to survive for more than 3 months.
12) Written informed consent.
Key exclusion criteria 1) Active infection or other serious disease condition (poorly controlled diabetes mellitus,cardiac disease,Unstable angina,Cardiac infarction, Psychological illness, etc.).
2) Pulmonary disorder(idiopathic pulmonary fibrosis,interstitial lung disease,pneumoconiosis,active radiation pneumonia,etc.).
3) Massive pleural effusion, pericardial effusion, ascites, and superior vena cava syndrome.
4) Symptomatic brain metastasis.
5) Severe drug allergy.
6) Previous radiotherapy to primary lung cancer.
7) Patients who have previously treated three or more chemotherapy.
8) Patients who had a relapse after surgery.
9) With active double cancer.
10) Pregnancy or lactation.
11) Severe disorder of the eye.
12) Patients whose participation in the trial is judged to be inappropriate by the attending doctor.
Target sample size 83

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinori Hasegawa
Organization Nagoya University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 65 Tsurumaicho, Showo-ku, Nagoya-City, Aichi, 466-8550, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masashi Kondo, Masahiro Morisse, Tetsunari Hase
Organization Nagoya University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address cjlsg@med.nagoya-u.ac.jp
TEL
Homepage URL
Email

Sponsor
Institute Central Japan Lung Study Group (CJLSG)
Institute
Department

Funding Source
Organization Central Japan Lung Study Group (CJLSG)
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
2011 Year 06 Month 16 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 Terminated
Date of protocol fixation
2011 Year 04 Month 13 Day
Date of IRB
Anticipated trial start date
2011 Year 06 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 Additional study of CJLSG0903/0904.
Blood draw before Erlotinib treatment.

Management information
Registered date
2011 Year 06 Month 10 Day
Last modified on
2018 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006802

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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