UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study of Neoadjuvant chemoradiotherapy for locally advanced esophageal carcinoma
Title of the study (Brief title)	NeoCRT trial
Region	Japan

Condition
Condition	Esophageal Cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the feasibility of neoadjuvant chemoradiotherapy with 5-FU and CDDP for resectable locally advanced esophageal cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Completion proportion of curative surgery
Key secondary outcomes	Overall survival, Progression free survival, curative resection rate, Response rate for CRT Pathological CR rate Acute toxicity Late toxicity Surgical toxicity

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	Chemoradiotherapy(5-FU+CDDP+RT) Surgery
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)Historically proven squamous cell or adeon-squamous cell carcinoma. 2)Thoracic esophageal cancer 3)Clinical T2-3N0M0 or T1-3N1M0 (UICC6th) 4)Age more than 20years and less than 75 years. 5)ECOG performance status of 0,1 or 2. 6)Patients who had any evaluable lesion. 7)No prior therapy for esophageal cancer except curative endoscopic therapy. 8)No prior chemotherapy or radiotherapy for other cancr. 9)No palsy of recurrent nerve 10)Required baseline laboratory parameters (within 7 days before registration): Hb more than 10.0g/dl Neutrophil more than 2000/ul Plt more than 100,000/ul T-Bil less than 1.5mg/dl GOT less than 100 IU/l GPT less than 100 IU/l Ccr more than 60mg/min 11)The patients who were considered to be undergone transthoracic esophagectomy with D2 lymphonode dissection. 12)Signed informed consent of the patient for the registration.
Key exclusion criteria	1)active other malignancies within 5 years 2)Pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant, men who don't intend to have protected intercourse. 3)Unsuitable mental status and condition for clinical trials. 4)Patients who received ontinuous steroids (orally or intravenous) administration. 5)Positive HBsAg. 6)Unstable diabetes mellitus with oral hypoglycemic agent or insulin. 7)Acute myocardial infarction within 3 months 8)severe complications (COPD, interstitial lung disease, pulmonary fibrosis, heart failure and so on) 9)clinically significant infectious disease(body temperature less than 38.0 degrees) 10)Any other cases who are regarded as inadequate for study enrollment by the investigator.
Target sample size	60

Research contact person
Name of lead principal investigator	Ken Kato
Organization	National Cancer Center Hospital
Division name	Gastrointestinal Oncology Division
Address	5-1-1 Tsukiji Chuo-ku Tokyo
TEL	03-3542-2511
Email	kenkato@ncc.go.jp

Public contact
Name of contact person	Jun Hashimoto
Organization	National Cancer Center Hospital
Division name	Gastrointestinal Oncology Division
Address	5-1-1 Tsukiji Chuo-ku Tokyo
TEL	03-3542-2511
Homepage URL
Email	kenkato@ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital
Institute
Department

Funding Source
Organization	Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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	国立がん研究センター中央病院(東京都） 国立がん研究センター東病院（千葉県） 栃木県立がんセンター（栃木県） 静岡県立静岡がんセンター（静岡県） 千葉大学医学部(千葉県）

Other administrative information
Date of disclosure of the study information	2010 Year 09 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 03 Month 08 Day
Anticipated trial start date	2010 Year 07 Month 01 Day
Last follow-up date	2013 Year 07 Month 01 Day
Date of closure to data entry	2013 Year 12 Month 01 Day
Date trial data considered complete	2013 Year 12 Month 01 Day
Date analysis concluded	2014 Year 07 Month 01 Day

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

Management information
Registered date	2010 Year 09 Month 16 Day
Last modified on	2018 Year 10 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005074