UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022165 |
|---|---|
| Receipt number | R000025296 |
| Scientific Title | S-1 as second line for non-small cell lung cancer with preexisting interstitial pneumonia: phase II study. |
| Date of disclosure of the study information | 2016/05/11 |
| Last modified on | 2018/07/11 22:02:07 |
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Basic information
Public title
S-1 as second line for non-small cell lung cancer with preexisting interstitial pneumonia: phase II study.
Acronym
S-1 as 2nd line for NSCLC with IP
Scientific Title
S-1 as second line for non-small cell lung cancer with preexisting interstitial pneumonia: phase II study.
Scientific Title:Acronym
S-1 as 2nd line for NSCLC with IP
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy and safety of S-1 as second line for non-small cell lung cancer with preexisting interstitial pneumonia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
progression free survival (PFS)
Key secondary outcomes
overall survival
1 year survival rate
response rate
disease control rate
safety
incidence of acute exacerbation of preexisting interstitial pneumonia
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
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, day 1- 28, q6w.
body surface area (BSA) >1.5m2 S-1 80 mg/day
BSA 1.25 - 1.5m2 S-1 100 mg/day
BSA > 1.5m2 S-1 120 mg/day
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) pathologically confirmed non small cell lung cancer
2) stage IIIB/IV or relapsed patients who received anti-cancer agents once.
3) patients with preexisting interstitial pneumonia
4) more than 20 years old
5) ECOG PS 0-2
6) life expectancy for more than 3 months
7) more than one measurable lesion
8) ability to take medications per oral
9) preserved main organs function
10) Informed consent with documents by participants.
Key exclusion criteria
1) deterioration of preexisting interstitial pneumonia within 3 months (acute/sub-acute cases)
2) history of acute exacerbation of preexisting interstitial pneumonia or drug induced lung injury.
3) taking corticosteroids more than 15 mg/day of prednisolon or equal
4) taking immunosuppressant
5) received irradiation to lung within 3 months
6) using home oxygen therapy (HOT)
7) history of treatment with fluorinated pyrimidine
8) contraindicated for S-1
9) symptomatic, unstable brain metastasis
10) with pleural or peritoneal effusions which need to be drainage
11) with watery diarrhea
12) with severe comorbidities considered to be obstacle for anti-cancer therapy.
13) with metachronous or synchronous multiple cancer
14) using flucytosine
15) being pregnant or have an intention to be or make pregnant, or breast feeding.
16) considered as inappropriate to be participant by the primary physician
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takafumi Suda |
Organization
Hamamatsu University School of Medicine
Division name
2nd division, Department of Internal Medicine
Zip code
Address
1-20-1 Handayama, Higashi Ward, Hamamatsu, Shizuoka, Japan. 431-3192
TEL
053-435-2111
suda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norimichi Akiyama |
Organization
Hamamatsu University School of Medicine
Division name
2nd division, Department of Internal Medicine
Zip code
Address
1-20-1 Handayama, Higashi Ward, Hamamatsu, Shizuoka, Japan. 431-3192
TEL
053-436-1251
Homepage URL
nakiyan@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2016 | Year | 05 | Month | 11 | 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
Date of protocol fixation
| 2016 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 02 | Day |
Last modified on
| 2018 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025296
