UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000031672
Receipt number	R000036173
Scientific Title	Prospective observational study on the evaluation of antitumor effect of simultaneous combination chemoradiotherapy due to change in Apparent Diffusion Coefficient values of esophageal squamous cell carcinoma in magnetic resonance diffusion emphasized imaging
Date of disclosure of the study information	2018/04/01
Last modified on	2023/09/14 11:56:31

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Basic information

Public title

Prospective observational study on the evaluation of antitumor effect of simultaneous combination chemoradiotherapy due to change in Apparent Diffusion Coefficient values of esophageal squamous cell carcinoma in magnetic resonance diffusion emphasized imaging

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Esophageal squamous cell carcinoma

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

Measure changes in the apparent diffusion coefficient (APC value) of cT3 - T4 esophageal squamous cell carcinoma in magnetic resonance imaging (MRI) before and during radiochemotherapy. We evaluate the relationship between these measurement results and tumor reduction rate after radiochemotherapy.
By doing this, it is the main endpoint to examine the usefulness of ADC value measurement as antitumor effect predictor.

Basic objectives2

Others

Basic objectives -Others

In addition, we will investigate overall survival rate, relapse-free survival rate and prognostic predictor as secondary endpoints.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Relationship between changes within the 14 days before radiochemotherapy by ADC value measurement and at 20 Gy point after treatment start and tumor reduction ratio

Key secondary outcomes

Overall survival rate and relapse-free survival rate and prognostic factors

Base

Study type

Observational

Study design

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

79 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) disease name
Esophageal cancer squamous cell carcinoma not treated
(2) stage
cT3 - T4, lymph node metastasis or distant metastasis (UICC 7th edition)
(3) Age 20 years old, under 79 years (when registering)
(4) Gender
There is no problem in gender.
(3) Performance Status 0-3
(4) Multiple cases of active duplication cancer.
(5) Bone marrow and organ function that satisfy the following conditions are preserved, and it can be predicted that radiation chemotherapy for simultaneous combination can be performed.
WBC 3000 / m 3 or more, PLT 100000 / m 3 or more, Hb 10 g / dl or more
AST 75 IU / l or less, ALT 75 IU / l or less, T-Bil 1.5 mg / dl or less
Cr: 1.2 mg / dl or less, Ccr (measured value): 50 ml / min / body or more
(6) With regard to participation in this clinical trial, his / her consent has been obtained in writing.
(7) Gastrointestinal disorder Treatment was selected by consultation of the department of gastroenterology, gastrointestinal surgery, tumor internal medicine, radiotherapy department in consideration of past history, internal organs function, patient's and family's desire Case.

Key exclusion criteria

(1) Patients with history of chemotherapy or radiotherapy to the chest against esophageal cancer or other diseases.
(2) Cases after esophagus cancer mucosal resection.
(3) Simultaneous duplicated cancer cases of active requiring treatment. Or cases with a disease-free period of less than 3 years even if they are metachronous.
(4) Cases with severe complications such as poorly controlled diabetes, collagen diseases, heart diseases, lung diseases, kidney diseases, psychiatric disorders and the like which are expected to be unable to withstand the present test protocol
(5) Pregnant women, lactating women and cases of possible pregnancy.
(6) Cases in which active infection has been proven and has a fever of 38 degrees or more.
(7) Cases in which steroids are routinely used.
(8) Case with pacemaker or internal defibrillator.
(9) Cases in which confirmation of intention can not be performed.
(10) Cases in which MRI imaging can not be performed.
(11) Other cases that the doctor in charge deemed inappropriate as a subject.

Target sample size

Research contact person

Name of lead principal investigator

1st name Keiichi

Middle name

Last name Jingu

Organization

Tohoku University Graduate School

Division name

Graduate School of Medicine Department of Radiation Oncology

Zip code

9808574

Address

Tohoku University, 1-1, Seiryocyou, Aoba-ku, Sendai, Miyag

TEL

022-717-7312

Email

kjingurad@yahoo.co.jp

Public contact

Name of contact person

1st name Yu

Middle name

Last name Suzuki

Organization

Tohoku University Graduate School

Division name

Graduate School of Medicine Department of Radiation Oncology

Zip code

9808574

Address

Tohoku University, 1-1, Seiryocyou, Aoba-ku, Sendai, Miyagi

TEL

022-717-7312

Homepage URL

Email

rsb09592@gmail.com

Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name

Funding Source

Organization

Tohoku University

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

Tohoku University Graduate School of Medicine Ethics Committee

Address

Tohoku University, 1-1, Seiryocyou, Aoba-ku, Sendai, Miyagi

Tel

022-728-4105

Email

med-kenkyo@grp.tohoku.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2018 Year 04 Month 01 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

No longer recruiting

Date of protocol fixation

2017 Year 12 Month 18 Day

Date of IRB

2017 Year 12 Month 18 Day

Anticipated trial start date

2018 Year 01 Month 01 Day

Last follow-up date

2023 Year 01 Month 31 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Prospective study

Management information

Registered date

2018 Year 03 Month 11 Day

Last modified on

2023 Year 09 Month 14 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036173

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name