UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006527 |
|---|---|
| Receipt number | R000007738 |
| Scientific Title | Phase 2 study of S-1 for elderly patients with advanced non-small cell lung cancer |
| Date of disclosure of the study information | 2011/10/12 |
| Last modified on | 2020/11/02 16:59:55 |
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Basic information
Public title
Phase 2 study of S-1 for elderly patients with advanced non-small cell lung cancer
Acronym
Phase 2 study of S-1 for elderly patients with advanced non-small cell lung cancer
Scientific Title
Phase 2 study of S-1 for elderly patients with advanced non-small cell lung cancer
Scientific Title:Acronym
Phase 2 study of S-1 for elderly patients with advanced non-small cell lung cancer
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate efficacy and safety of S-1 for elderly patients with stage 3B/4 non-small Cell Lung Cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Progression-free survival, Overall survival, Safety, To explore EGFR status and K-ras status related to the effect.
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
S-1
50-120 mg/day, day1-14 every 3 weeks
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Histologically or cytologically proven non-small cell lung cancer.
2)Clinical stage IIIB, IV or recurrent disease after surgery.
3)With at least one or more measurable lesion by RECIST.
4)Aged 70 years or older.
5)ECOG performance status of 0 or 1.
6)No prior chemothearpy or radiotherapy for non-small Cell Lung Cancer.
7)Adequate organ function.
8)Oral intake is possible.
9)Life expectancy more than 3 months.
10)Written informed consent.
Key exclusion criteria
1)Active lung disease such as interstitial pneumonia or pulmonary fibrosis.
2)Uncontrollable pleural or pericardial effusion or ascites.
3)Simultaneous or metachronous double cancers.
4)Severe complications.
5)Symptomatic brain metastases.
6)The case suspected of infection with feaver.
7)Mental disease or psychotic manifestation.
8)A history of serious drug allergy.
9)A history of sever allergic reaction with S-1
10)A history of adjuvant chemotherapy including S-1.
11)Being treated with other pyrimidine fluoride antineoplastic agents.
12)Being treated with flucytosine.
13)Any patients judged by the investigator to be unfit to participate in the study.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriyuki Masuda |
Organization
Kitasato University School of Medicine
Division name
Department of Respiratory Medicine
Zip code
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374, Japan
TEL
042-778-8111
masuda@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Takakura |
Organization
Kitasato University School of Medicine
Division name
Department of Respiratory Medicine
Zip code
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374, Japan
TEL
042-778-8111
Homepage URL
takakura@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Department of Respiratory Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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 | 10 | Month | 12 | 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
Completed
Date of protocol fixation
| 2010 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2010 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2010 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 12 | Day |
Last modified on
| 2020 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007738
