UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028542
Receipt number R000032668
Scientific Title A prospective study about efficacy and safety of selective arterial injection chemotherapy for ineffective or intorelable to the standard chemotherapy in advanced esophageal cancer
Date of disclosure of the study information 2017/08/05
Last modified on 2017/08/04 22:45:43

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Basic information

Public title

A prospective study about efficacy and safety of selective arterial injection chemotherapy for ineffective or intorelable to the standard chemotherapy in advanced esophageal cancer

Acronym

A prospective study of selective arterial injection chemotherapy for limited advanced esophageal cancer

Scientific Title

A prospective study about efficacy and safety of selective arterial injection chemotherapy for ineffective or intorelable to the standard chemotherapy in advanced esophageal cancer

Scientific Title:Acronym

A prospective study of selective arterial injection chemotherapy for limited advanced esophageal cancer

Region

Japan


Condition

Condition

Esophagus

Classification by specialty

Gastroenterology Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Radiology Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safty of selective arterial injection chemotherapy for advanced esophageal cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Tumor regression effect

Key secondary outcomes



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

Maneuver

Interventions/Control_1

selective arterial injection chemotherapy

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)Neoadjuvant chemotherapy for advanced esophageal cancer
2)Cases of ineffective for first FP chemotherapy(SD,PD)
3)Cases of intolerable for other therapies
4)Cases of impossible for other therapies

Key exclusion criteria

1)Impossible for catheter treatment
2)below 20 years old
3)pregnant
4)No informed consent
5)Inappreciate patients

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Haruhiro Inoue

Organization

Showa University Koto Toyosu Hospital

Division name

Digestive Diseases Center

Zip code


Address

5-1-38,Toyosu, Koto-ku, Tokyo

TEL

03-6204-6000

Email

haruinoue777@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Manabu Onimaru

Organization

Showa University Koto Toyosu Hospital

Division name

Digestive Diseases Center

Zip code


Address

5-1-38,Toyosu, Koto-ku, Tokyo

TEL

03-6204-6000

Homepage URL


Email

mnbonmr0827@gmail.com


Sponsor or person

Institute

Showa University Koto Toyosu Hospital

Institute

Department

Personal name



Funding Source

Organization

Showa University Koto Toyosu Hospital

Organization

Division

Category of Funding Organization

Other

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 08 Month 05 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

Preinitiation

Date of protocol fixation

2017 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2017 Year 08 Month 05 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 08 Month 04 Day

Last modified on

2017 Year 08 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032668


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name