UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011795 |
|---|---|
| Receipt number | R000012374 |
| Scientific Title | A Feasibility study of alternate-day administrations of TS-1 as previously treated advanced non-small cell lung cancer in elderly patients |
| Date of disclosure of the study information | 2013/09/18 |
| Last modified on | 2017/03/23 12:45:29 |
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Basic information
Public title
A Feasibility study of alternate-day administrations of TS-1 as previously treated advanced non-small cell lung cancer in elderly patients
Acronym
A Feasibility study of alternate-day administrations of TS-1 as previously treated advanced non-small cell lung cancer in elderly patients
Scientific Title
A Feasibility study of alternate-day administrations of TS-1 as previously treated advanced non-small cell lung cancer in elderly patients
Scientific Title:Acronym
A Feasibility study of alternate-day administrations of TS-1 as previously treated advanced non-small cell lung cancer in elderly patients
Region
| Japan |
Condition
Condition
Previously treated non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safty of alternate-day administrations of TS-1 as previously treated advanced non-small cell lung cancer in elderly patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Safety
Key secondary outcomes
1yr OS,PFS,DCR
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
administration of TS-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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Histologically or cytologically confirmed Stage IIIB,IV non-
squamous non-small cell lung cancer
2)Stage III,IV non-small cell lung cancer without any indications for radiotherapy
3)75<= years
4)Performance Status (ECOG):0-1
5)Previously treated one or more chemotherapy regimens
6)A life expectancy of more than 3 months
7)Patients who can take in drug orally
8)Adequate function of vital organs, including normal hematopoietic
liver and renal function as following:
WBC >= 3,000/mm3
Neutrophils >= 1,500/mm3
Platelets >= 100,000/mm3
Hemoglobin >= 9.0 g/dL
Total bilirubin <= 1.5mg/mL
AST and ALT, x2.5 of upper limit of normal(ULN) or less
Serum creatinine <= 1.5mg/dL
Creatinin crealance>=50mL/min
Key exclusion criteria
1) Interstitial pneumonia or pulmonary fibrosis detectable on X ray.
2) Massive pleural or pericardial effusion,ascites
3) History of active double cancer within 5 years prior to the study.
4) Patients having active other cancers.
5) Ileus, Interstitial
6) Uncontrolled diabetes mellitus
7) Cardiac infarction or unstable angina within 6 months
8) Symptomatic brain metastases
9) Concomitant therapy with flucytocine, phenytoin or Warfarin
Potassium
10) Serious psychiatric illness
11) History of severe hypersensitivity(>=Grade3)
12) History of using 5-FU o
13) Patient who is not candidates for TS-1
14) HBV-positive patients
15) Evaluated to be ineligible by a physician for other reasons
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noboru Hattori |
Organization
Hiroshima University Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
1-2-3,Kasumi,Minami-ku, Hiroshima,Japan
TEL
082-257-5196
nhattori@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunori Fujitaka |
Organization
Hiroshima University Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
1-2-3,Kasumi,Minami-ku, Hiroshima,Japan
TEL
082-257-5196
Homepage URL
fujikazu@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
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
安佐市民病院（広島県）、広島赤十字原爆病院（広島県）、 広島市民病院（広島県）、県立広島病院（広島県）、JA広島総合病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 18 | 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
| 2013 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 18 | Day |
Last modified on
| 2017 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012374
