UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of neoadjuvant DCF therapy followed by adjvant S-1 monotherapy for pathological lymph node metastacis cases for locally advanced esophageal cancer.
Acronym	Phase II study of neoadjuvant DCF followed by adjvant S-1 for pN+ forn locally advanced esophageal cancer.
Scientific Title	Phase II study of neoadjuvant DCF therapy followed by adjvant S-1 monotherapy for pathological lymph node metastacis cases for locally advanced esophageal cancer.
Scientific Title:Acronym	Phase II study of neoadjuvant DCF followed by adjvant S-1 for pN+ forn locally advanced esophageal cancer.
Region	Japan

Condition
Condition	Esophageal cancer
Classification by specialty	Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety and efficacy of neoadjuvant DCF therapy followed by adjvant S-1 monotherapy for pathological lymph node metastacis cases for locally advanced esophageal cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Recurrence free survival(RFS)
Key secondary outcomes	Overall survival(OS) Response rate(RR) R0 resction rate pN positive rate Adverse events

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 DCF therapy followed by adjvant S-1 monotherapy for pathological lymph node metastacis cases for locally advanced esophageal cancer
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.Histologically confirmed esophageal squamous cell carcinoma, adenosquamous carcinoma, or basal cell carcinoma 2.Clinical stage II or III (excluding T4) according to the 7th UICC-TNM classification 3.Age over 20 years old. 4.Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. 5.With or without evaluable lesions according to RECIST ver 1.1. 6.No prior treatment for esophageal cancer, except for (i)-(ii): (i)The depths of invasion are diagnosed as tumor invades lamina propria mucosa(pT1a-LPM) after a curative endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) for esophageal cancer. (ii)The depths of invasion are diagnosed as tumor invades muscularis mucosa(pT1a-MM) and vascular invasion negative after a previous curative EMR or ESD for esophageal cancer. 7.No prior treatment of chemotherapy, radiotherapy or endocrine therapy against any other malignant tumors, except for hormone therapy for prostate cancer, which has improved before 5 years. 8.Adequate organ functions 9.R0 esophagectomy is expected 10.Written informed consent
Key exclusion criteria	1.Synchronous or metachronous (within 5 years) double cancers, except for intoramucosal tumor curatively resected by local therapy 2.With active systemic infection disease 3.With active hepatitis B or C 4.With HIV infection 5.With a history of interstitial pneumonia, pulmonary fibrosis or irradiation pneumonitis 6.Severe psychological illness. 7.With continuous systemic steroid or immune-suppressive drug therapy. 8.Poorly controlled diabetes mellitus or thyroid diseases. 9.Unstable angina within 3 weeks or with a history of acute myocardial infarction within 3months 10.With a history of hypersensitivity to docetaxel, cisplatin or polysorbate 80-containing formulations 11.Pregnant and/or nursing women or men who wish to have children in future 12.Judged to be unfit to participate in this study by investigator
Target sample size	55

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasuyuki Seto
Organization	The University of Tokyo
Division name	Department of Gastrointestinal Surgery
Zip code
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411
Email	seto-tky@umin.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yasuyoshi Sato
Organization	The University of Tokyo
Division name	Department of Gastrointestinal Surgery
Zip code
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411
Homepage URL
Email	yasuyoshi_s@hotmail.com

Sponsor
Institute	The University of Tokyo
Institute
Department

Funding Source
Organization	Self funding
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	2017 Year 07 Month 01 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	Open public recruiting
Date of protocol fixation	2017 Year 06 Month 22 Day
Date of IRB
Anticipated trial start date	2017 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 06 Month 01 Day
Last modified on	2019 Year 02 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030083

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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