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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036387
Receipt No. R000025117
Scientific Title Phase I study of nedaplatin and S-1 in patients with advanced or relapsed squamous cell lung cancer
Date of disclosure of the study information 2019/04/02
Last modified on 2020/10/02

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Basic information
Public title Phase I study of nedaplatin and S-1 in patients with advanced or relapsed squamous cell lung cancer
Acronym Phase I study of nedaplatin and S-1 in patients with advanced or relapsed squamous cell lung cancer
Scientific Title Phase I study of nedaplatin and S-1 in patients with advanced or relapsed squamous cell lung cancer
Scientific Title:Acronym Phase I study of nedaplatin and S-1 in patients with advanced or relapsed squamous cell lung cancer
Region
Japan

Condition
Condition Squamous cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the maximum dose of nedaplatin and S-1 in patients with advanced or relapsed squamous cell lung cancer
Basic objectives2 Others
Basic objectives -Others determination of maximum dose and estimation of recommendation dose
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes determination of maximum dose and estimation of recommendation dose
Key secondary outcomes

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 Nedaplatin is administered on day 1 and S-1 is administered for 2 weeks (day 1 to 14).
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1)Histologically or cytologically confirmed squamous cell lung cancer.
2)stage III-IV without indication of curative radiotherapy and surgery, or relapsed case after surgery.
3)no more than 75 years-old
4)PS 0-1
Key exclusion criteria 1)Severe complication
2)interstitial penumonia
3)positive for HBs antigen
4)Pleural effusion, ascites, or pericardial effusion which need drainage
5)double malignancy
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Nobuhiro
Middle name
Last name Kanaji
Organization Kagawa University
Division name Department of Internal Medicine, Division of Hematology, Rheumatology and Respiratory Medicine
Zip code 761-0793
Address 1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL 087-891-2145
Email kanaji@med.kagawa-u.ac.jp

Public contact
Name of contact person
1st name Nobuhiro
Middle name
Last name Kanaji
Organization Kagawa University
Division name Department of Internal Medicine, Division of Hematology, Rheumatology and Respiratory Medicine
Zip code 761-0793
Address 1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL 087-891-2145
Homepage URL
Email kanaji@med.kagawa-u.ac.jp

Sponsor
Institute Kagawa University
Institute
Department

Funding Source
Organization Kagawa University
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 Kagawa University
Address 1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
Tel 087-891-2345
Email chiken@med.kagawa-u.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
2019 Year 04 Month 02 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 9
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
2012 Year 01 Month 31 Day
Date of IRB
2012 Year 07 Month 31 Day
Anticipated trial start date
2012 Year 07 Month 31 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
2020 Year 02 Month 14 Day
Date analysis concluded
2020 Year 07 Month 28 Day

Other
Other related information

Management information
Registered date
2019 Year 04 Month 02 Day
Last modified on
2020 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025117

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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