UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005754 |
|---|---|
| Receipt number | 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 19:35:55 |
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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
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
Sponsor or person
Institute
Central Japan Lung Study Group (CJLSG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006802
