UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I study on the feasibility of Nedaplatin plus S-1 combination therapy for squamous cell lung cancer.
Title of the study (Brief title)	Nedaplatin plus S-1 combination therapy for 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	The feasibility of Nedaplatin plus S-1 combination therapy for squamous cell lung cancer and dose of Nedaplatin are tested.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Determination of recommended dose of nedaplatin in the case of combination with S-1
Key secondary outcomes	Safety, Drug adherence rate, response rate

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 plus S-1
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. Patient who had squamous lung cancer, neither surgery nor radiation indication, accompanied by anti-cancer chemotherapy 2. Informed consent is obtained 3.Patient who is judged as an appropriate case by the doctor in charge 4. PS0-1 5. No history of cardiac failure, renal failure, or liver damage.
Key exclusion criteria	1. Patient who have severe infection 2. Pregnant or lactating women. 3. Multiple cancer 4. A known history of allergy 5. A known history of GI bleeding 6. Patient who have interstitial pneumonia 7. Patient who have severe diabetes mellitus, liver cirrhosis, renal dysfunction, angina pectoris, arrhythmia, or myocardiac infarction before 3 months 8. Patient who have therapeutic need of pleural effusion, pericardiac effusion, or SVC syndrome 9. Patient who have obscure symptoms of brain metastasis. 10. Patient who have obscure symptoms of peripheral nerve dysfunction 11. Patient who take flucytosin.of brain 12. Patient who have severe 13.patient who is judged as an inappropriate case by the doctor in charge
Target sample size	18

Research contact person
Name of lead principal investigator	Masaki Fujita
Organization	Fukuoka University Hospital
Division name	Respiratory Medicine
Address	7-45-1 Nanakuma, Jonanku, Fukuoka
TEL	092-801-1011
Email	mfujita@fukuoka-u.ac.jp

Public contact
Name of contact person	Masaki Fujita
Organization	Fukuoka University Hospital
Division name	Respiratory Medicine
Address	7-45-1 Nanakuma, Jonanku, Fukuoka
TEL	092-801-1011
Homepage URL
Email	mfujita@fukuoka-u.ac.jp

Sponsor
Institute	Fukuoka University Hospital
Institute
Department

Funding Source
Organization	Department of Respiratory Medicine, Fukuoka University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	福岡大学病院（福岡県） 福岡大学筑紫病院（福岡県）

Other administrative information
Date of disclosure of the study information	2013 Year 02 Month 18 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 02 Month 05 Day
Anticipated trial start date	2013 Year 03 Month 01 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Because of shortage of case accumulation, the study was terminated.
Other related information

Management information
Registered date	2013 Year 02 Month 07 Day
Last modified on	2018 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011703