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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003422
Receipt No. R000004122
Scientific Title A phase II study of erlotinib/S-1 combination therapy in patients with recurrent or advanced non-small lung cancer who do not possess active EGFR mutation.(TORG0913)
Date of disclosure of the study information 2010/03/31
Last modified on 2014/07/18

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Basic information
Public title A phase II study of erlotinib/S-1 combination therapy in patients with recurrent or advanced non-small lung cancer who do not possess active EGFR mutation.(TORG0913)
Acronym A phase II study of erlotinib/S-1 combination therapy in patients with recurrent or advanced non-small lung cancer who do not possess active EGFR mutation.(TORG0913)
Scientific Title A phase II study of erlotinib/S-1 combination therapy in patients with recurrent or advanced non-small lung cancer who do not possess active EGFR mutation.(TORG0913)
Scientific Title:Acronym A phase II study of erlotinib/S-1 combination therapy in patients with recurrent or advanced non-small lung cancer who do not possess active EGFR mutation.(TORG0913)
Region
Japan

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

Objectives
Narrative objectives1 To evaluate efficacy and safety of erlotinib/S-1 combination therapy in
patients with recurrent or advanced NSCLC who do not possess active EGFR mutation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Disease control rate(DCR), Progression free survival(PFS), Overall survival(OS), safety

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 Treatment
Type of intervention
Medicine
Interventions/Control_1 Erlotinib is administered 150mg/body day orally every day.
S-1 is administered 40 mg/m2 twice daily(after breakfast and dinner), days 1-14 every 21 days orally.
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)Histology/cytology-proven non-small cell lung cancer
2)Stage IIIB (wide radiation field, malignant pleural effusion or contralateral supraclavicular lymph
node) or Stage IV
3)Previous 1-or 2-regimen chemotherapy consisting of platinum
4)patients who do not possess active
EGFR mutation
5)No prior chemotherapy with EGFR-TKI or
fluoropyrimidine
6)possible cases with oral administration
7)Performance status (ECOG)0-2
8)Presence of measurable disease per RECIST criteria
9)close and meticulous observation with (or without hospitalization) during the first 2-4 weeks of treatment
10)Age of 20 years or over
11)Adequate reserves for marrow, renal, hepatic, and pulmonary functions t
12)more than 4 weeks after the last chemotherapy
13)Acquisition of written informed consent
Key exclusion criteria 1)no other evaluable lesion after the prior irradiation for the primary tumor
2)the superior vena caval syndrome
3)previous drug allergy
4)massive pericardial effusion, or ascites
5,8,16)serious underlying diseases(interstitial pneumonia, serious cardiac diseases, serious infection)
6,7)diarrhea to last, ileus, or intestinal tract paralysis
9)symptomatic ophthalmologic disease
10)current or previous (within the last 1 year)history of GI perforation
11)serious non-healing ulcer
12)symptomatic or steroid-requiring brain metastases
13,14)active concomitant malignancy
15)uncontrolled diabetes mellitus
17)severe psychological disease
18)hoped to be pregnant/nursing
19)those judged to be not suitable by the attending physician
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsu Shinkai
Organization National hospital organization shikoku cancer center
Division name department of respiratory disease
Zip code
Address 160,Minamiumemoto-machi-ko,matsuyama,Ehime
TEL 089-999-1111
Email teshinkai@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Naoyuki Nogami
Organization National hospital organization shikoku cancer center
Division name Administration office
Zip code
Address 160,Minamiumemoto-machi-ko,matsuyama,Ehime
TEL 089-999-1111
Homepage URL http://www.torg.or.jp/
Email Nnogami@shikoku-cc.go.jp

Sponsor
Institute Thoracic Oncology Research Group
Institute
Department

Funding Source
Organization Thoracic Oncology Research Group
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization japan

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
2010 Year 03 Month 31 Day

Related information
URL releasing protocol http://www.torg.or.jp/
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
2010 Year 02 Month 23 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
2012 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 03 Month 31 Day
Last modified on
2014 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004122

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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