UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study of neoadjuvant chemotherapy with docetaxel, cisplatin, and S-1 in advanced esophageal cancer patients with normal oral intake
Acronym	A phase II study of neoadjuvant chemotherapy with DCS for esophageal cancer
Scientific Title	A phase II study of neoadjuvant chemotherapy with docetaxel, cisplatin, and S-1 in advanced esophageal cancer patients with normal oral intake
Scientific Title:Acronym	A phase II study of neoadjuvant chemotherapy with DCS for esophageal cancer
Region	Japan

Condition
Condition	esophageal cancer
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This phase II study is being conducted to determine the efficacy of neoadjuvant chemotherapy using docetaxel, cisplatin and S-1 (DCS) for stage IB/II/III esophageal cancer with normal oral intake
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Pathologocal response
Key secondary outcomes	Curative resection rate Clinical response of chemotherapy Toxicities of chemotherapy Postoperative complication 2y survival rate 3y survival rate

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Chemotherapy using Docetaxel+Cisplatin+S-1 followed by surgicalresection
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) Patients must have historogic confirmation of squamous cell carcinoma or adenocarcinoma or basaloid carcinoma by endoscopic biopsy (2) TMN stage IB/II/III (3) 20 years and older, 75 years and younger (4) ECOG performance status 0-1 (5) Patients have not received prior chemotherapy or radiotherapy (6) Patients who are going to under curative esophagectomy (R0) (7) Patients with normal oral intake (8) Lavoratory values as fellows; 4000 < WBC < 12000/mm3 granulocyte count > 2000/mm3 Hemoglobin > 8.0 g/dL Platelet count > 100,000/mm3 AST, ALT < 100 IU/L T-bil < 1.5 mg/dL Cr < 1.2 mg/dL Ccr > 60 mL/min/body
Key exclusion criteria	(1)Patients with concurrent other primary cancer requiring treatment (2)Pregnancy, possible pregnancy after delivery or breast feeding (3)Patients requiring systemic administration of steroid (4)Positive HBs antigen (5)Patients requiring flucytosine or phenytoin or warfarine administration (6)Patients for allergy of iodine (7)Patient with allergic response to anticancer drugs (docetaxel, cisplatin, S-1) (8)Severe peripheral nerve disorder (9)Patients with interstitial pneumonia or pulmonary fibrosis (10)Active infection (11)Patients with a history of myocardial infarction or unstable angina pectoris within the previous six months (12)Patients with uncontrolled hypertension or diabetes melitus
Target sample size	40

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Mikihito Nakamori
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Zip code
Address	811-1 Kimiidera, Wakayama, Japan
TEL	073-441-0613
Email	chamcham@wakayama-med.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Mikihito Nakamori
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Zip code
Address	811-1 Kimiidera, Wakayama, Japan
TEL	073-441-0613
Homepage URL
Email	chamcham@wakayama-med.ac.jp

Sponsor
Institute	Second Department of Surgery, Wakayama Medical University
Institute
Department

Funding Source
Organization	Second Department of Surgery, Wakayama Medical University
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	2015 Year 04 Month 16 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	2014 Year 06 Month 20 Day
Date of IRB	2014 Year 06 Month 10 Day
Anticipated trial start date	2014 Year 07 Month 01 Day
Last follow-up date	2019 Year 03 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 04 Month 16 Day
Last modified on	2019 Year 03 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019895