UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of TS-1 + CPT-11 for squamous cell lung cancer previously treated with platinum
Acronym	TS-1+CPT-11 for platinum-resistant squamous cell lung cancer
Scientific Title	Phase II study of TS-1 + CPT-11 for squamous cell lung cancer previously treated with platinum
Scientific Title:Acronym	TS-1+CPT-11 for platinum-resistant squamous cell lung cancer
Region	Japan

Condition
Condition	Non-small cell lung cancer (squamous cell carcinoma)
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of TS-1+CPT-11
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Response rate
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	TS-1+CPT-11
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Pathologically proven squamous cell lung cancer 2. Previously treated with 1 or 2 regimen including at least one platinum regimen 3. With measurable lesion 4. With ECOG PS 0-1 5. With adequate organ function 6. With written informed consent
Key exclusion criteria	1. With obvious interstitial pneumonitis 2. With active other malignancies 3. With massive effusion required tube drainage 4. With severe comorbidities 5. With symptomatic brain metastasis 6. With other conditions that is considered inappropriate for the study by an attending physician
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Shunichi Middle name Last name Sugawara
Organization	Sendai Kousei Hospital
Division name	Respiratory medicine
Zip code	980
Address	4-15, Hirosemachi, Aobaku, Sendai, Japan
TEL	+81-22-222-6111
Email	swara357@cat-v.ne.jp

Public contact
Name of contact person	1st name Akira Middle name Last name Inoue
Organization	North Japan Lung Cancer Group
Division name	Office
Zip code	980-8575
Address	2-1, Seiryocho, Aobaku, Sendai
TEL	+81-22-717-8539
Homepage URL
Email	akinoue@idac.tohoku.ac.jp

Sponsor
Institute	North Japan Lung Cancer Group
Institute
Department

Funding Source
Organization	North Japan Lung Cancer Group
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	Tohoku University Hospital IRB
Address	2-1, Seiryomachi, Aobaku Sendai
Tel	022-717-7100
Email	akinoue@idac.tohoku.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	2011 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	30
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	2011 Year 07 Month 28 Day
Date of IRB	2011 Year 07 Month 27 Day
Anticipated trial start date	2011 Year 08 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 07 Month 28 Day
Last modified on	2020 Year 02 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007178