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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004223
Receipt No. R000005074
Scientific Title Feasibility study of Neoadjuvant chemoradiotherapy for locally advanced esophageal carcinoma
Date of disclosure of the study information 2010/09/16
Last modified on 2018/10/31

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Basic information
Public title Feasibility study of Neoadjuvant chemoradiotherapy for locally advanced esophageal carcinoma
Acronym NeoCRT trial
Scientific Title Feasibility study of Neoadjuvant chemoradiotherapy for locally advanced esophageal carcinoma
Scientific Title:Acronym 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
1st name
Middle name
Last name Ken Kato
Organization National Cancer Center Hospital
Division name Gastrointestinal Oncology Division
Zip code
Address 5-1-1 Tsukiji Chuo-ku Tokyo
TEL 03-3542-2511
Email kenkato@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jun Hashimoto
Organization National Cancer Center Hospital
Division name Gastrointestinal Oncology Division
Zip code
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)

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 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

Related information
URL releasing protocol
Publication of results Published

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
2010 Year 03 Month 08 Day
Date of IRB
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

Other
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

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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