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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014707
Receipt No. R000017036
Scientific Title Efficacy and safety of neoadjuvant chemotherapy by S-1 plus cisplatin for Stage III esophageal squamous cell carcinoma: A phase II trial
Date of disclosure of the study information 2014/07/30
Last modified on 2019/02/01

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Basic information
Public title Efficacy and safety of neoadjuvant chemotherapy by S-1 plus cisplatin for Stage III esophageal squamous cell carcinoma: A phase II trial
Acronym Neoadjuvant chemotherapy by S-1 plus cisplatin for esophageal squamous cell carcinoma
Scientific Title Efficacy and safety of neoadjuvant chemotherapy by S-1 plus cisplatin for Stage III esophageal squamous cell carcinoma: A phase II trial
Scientific Title:Acronym 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
Last name of lead principal investigator
1st name
Middle name
Last name Masahiko Koike
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterological Surgery
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL 052-744-2249
Email dockoike@med.nagoya-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Masahiko Koike
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterological Surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 04 Month 30 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000017036

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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