UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of neoadjuvant chemotherapy by S-1 plus cisplatin for Stage III esophageal squamous cell carcinoma: A phase II trial
Title of the study (Brief title)	Neoadjuvant chemotherapy by S-1 plus cisplatin for esophageal squamous cell carcinoma
Region	Japan

Condition
Condition	Esophageal squamous cell carcinoma
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of efficacy and safety of neoadjuvant chemotherapy by S-1 plus cisplatin for Stage III esophageal squamous cell carcinoma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Adverse event, 2 year survival rate, Progression free survival, Relative dose intensity, Pathological response

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	Neoadjuvant chemotherapy by S-1 plus cisplatin
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 confirmed esophageal squamous cell carcinoma 2) Clinical stage III according to the Japanese classification of esophageal cancer (10th edition) 3) Age between 20 and 75 at registration 4) Performance Status(ECOG) 0 or 1 5) No prior treatment of chemotherapy or radiation therapy against any other malignancies 6) Adequate organ function 7) Written informed consent from patient
Key exclusion criteria	1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ 2) Uncontrolled infection 3) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers 4) Psychiatric disease 5) Continuous systemic steroid therapy 6) Uncontrolled severe complications (DM, hypertension, diarrhea, et al.) 7) Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated 8) Symptomatic CNS metastasis 9) Interstitial lung disease or pulmonary fibrosis 10) Hypersensitivity for S-1 or cisplatin 11) Flucytosine, phenytoin, warfarin potassium or aminoglycoside antibiotic administration 12) Intestinal bleeding 13) Judged by physician inadequate for inclusion in this trial
Target sample size	30

Research contact person
Name of lead principal investigator	Masahiko Koike
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL	052-744-2249
Email	dockoike@med.nagoya-u.ac.jp

Public contact
Name of contact person	Masahiko Koike
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL	052-744-2249
Homepage URL
Email	dockoike@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Hospital
Institute
Department

Funding Source
Organization	None
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

Other administrative information
Date of disclosure of the study information	2014 Year 07 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 04 Month 30 Day
Anticipated trial start date	2011 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 07 Month 30 Day
Last modified on	2019 Year 02 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017036