UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003782 |
|---|---|
| Receipt number | R000004566 |
| Scientific Title | Phase I/II Trial of S-1 plus paclitaxel combination chemotherapy in elderly patients with non-small lung cancer |
| Date of disclosure of the study information | 2010/06/18 |
| Last modified on | 2024/12/28 09:49:44 |
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Basic information
Public title
Phase I/II Trial of S-1 plus paclitaxel combination chemotherapy in elderly patients with non-small lung cancer
Acronym
Phase I/II Trial of S-1 plus paclitaxel combination chemotherapy in elderly patients with non-small lung cancer
Scientific Title
Phase I/II Trial of S-1 plus paclitaxel combination chemotherapy in elderly patients with non-small lung cancer
Scientific Title:Acronym
Phase I/II Trial of S-1 plus paclitaxel combination chemotherapy in elderly patients with non-small lung cancer
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the maximum tolerated dose and recommended dose of S-1/PTX, and to investigate the efficacy and safety of the recommended dose for elderly patients with non-small-cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Phase I
maximum tolerated dose, recommended dose
Phase II
response rate
Key secondary outcomes
Phase I
toxicity, response rate
Phase II
toxicity, disease control rate, overall survival, relation to biomarker
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 plus Paclitaxel
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)Patients with NSCLC confirmed pathologically
2)Patients who have at least one or more measurable lesion
3)Unresectable stage IIIB or IV NSCLC
4)No previous chemotherapy or radiotherapy
5)An age more than 70 years or equal
6)Performance status (ECOG) :0-1
7)Adequate organ functions
8)A life expectancy of 2 months or more
9)With ability of oral intake
10)Written informed consent
Key exclusion criteria
1)Patients with serious complication
2)Patients with active double cancer
3)Patients with previous serious drug hyperseneitivity
4)receiving Flucytosine
5)Patients with alcohol allergy
6)Other conditions inadequate for this research
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Iwasaki |
Organization
Kyoto prefectural University of Medicine
Division name
Department of Respiratory Medicine
Zip code
602-8566
Address
Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602, Japan
TEL
075-251-5513
yiwasaki@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Iwasaki |
Organization
Kyoto prefectural University of Medicine
Division name
Department of Respiratory Medicine
Zip code
602-8566
Address
Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602, Japan
TEL
075-251-5513
Homepage URL
yiwasaki@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto prefectural University of Medicine
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
Kyoto Prefectural University of Medicine
Address
Hirokoji, Kawaramachi, kamigyo-ku, Kyoto
Tel
075-251-5513
yiwasaki-koto.kpu-m.ac.jp
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 | 06 | 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
Suspended
Date of protocol fixation
| 2010 | Year | 03 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | 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
| 2010 | Year | 06 | Month | 18 | Day |
Last modified on
| 2024 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004566
