UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000025117