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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000003782
Receipt No. 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 2016/12/22

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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
Middle name
Last name Yoshinobu Iwasaki
Organization Kyoto prefectural University of Medicine
Division name Department of Respiratory Medicine
Zip code
Address Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602, Japan
TEL 075-251-5513
Email yiwasaki@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinobu Iwasaki
Organization Kyoto prefectural University of Medicine
Division name Department of Respiratory Medicine
Zip code
Address Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602, Japan
TEL 075-251-5513
Homepage URL
Email yiwasaki@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto prefectural University of Medicine
Institute
Department

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
Address
Tel
Email

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
2016 Year 12 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004566

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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