UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004223
Receipt number 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 22:37:13

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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 or person

Institute

National Cancer Center Hospital

Institute

Department

Personal name



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

Value
https://center6.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