UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003422 |
|---|---|
| Receipt number | 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 | 2020/11/12 10:39:53 |
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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
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/
Nnogami@shikoku-cc.go.jp
Sponsor or person
Institute
Thoracic Oncology Research Group
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10637-020-00985-4
Number of participants that the trial has enrolled
10
Results
A total of 10 patients with PS 0, 1, or 2 EGFR-wild type NSCLC were enrolled in phase II. In phase II, the ORR was 10.0%, and the disease control rate (DCR) was 40.0%. After the enrollment of 10 subjects, enrollment was stopped based on two treatment-related deaths.
Results date posted
| 2020 | Year | 11 | Month | 12 | Day |
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
| 2020 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004122
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