UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020075
Receipt number R000023167
Scientific Title Phase II Randomized Radiation Dose Study of Concurrent Chemoradiotherapy With S-1 Plus Nedaplatin for Esophageal Cancer
Date of disclosure of the study information 2015/12/17
Last modified on 2018/12/12 09:04:18

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Basic information

Public title

Phase II Randomized Radiation Dose Study of Concurrent Chemoradiotherapy With S-1 Plus Nedaplatin for Esophageal Cancer

Acronym

Radiation Dose Study of CCRT with S-1 / NDP for Esophageal Cancer

Scientific Title

Phase II Randomized Radiation Dose Study of Concurrent Chemoradiotherapy With S-1 Plus Nedaplatin for Esophageal Cancer

Scientific Title:Acronym

Radiation Dose Study of CCRT with S-1 / NDP for Esophageal Cancer

Region

Japan


Condition

Condition

esophageal cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To compare the local control rates of 50.4Gy and 60Gy in CCRT for esophageal cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

2-year local control rate within PTV.

Key secondary outcomes

Overall survival, progression-free survival, frequency and degree of adverse events, and Quality of life in full observation period.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Device,equipment

Interventions/Control_1

S-1 80mg/ m2/day (day1-14, 29-42, po)
NDP 80mg/m2/day (day1, 29, iv)
Radiation therapy 1.8Gy/day, 28fractions (day1-38), 5 fractions/week, total 50.4Gy

Interventions/Control_2

S-1 80mg/ m2/day (day1-14, 29-42, po)
NDP 80mg/m2/day (day1, 29, iv)
Radiation therapy 2Gy/day, 30fractions (day1-40), 5 fractions/week, total 60Gy

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

a) Pathologically proven squamous cell carcinoma or adenocarcinoma of the esophagus
b) tumors can be included within a single irradiation field
c) age >= 20, <= 75
d) Karnofsky performance status : >= 70%
e) Patients with sufficient organ function
-WBC >= 3,000 /mm3
-Platelet >= 100,000 /mm3
-Hb >= 10 g/dL
-GOT, GTP <= 2.0 times upper limit of normal(ULN)
-T.Bil <= 1.5 mg/dL
-Creatinine <= 1.2 mg/dL
-Creatinine clearance or eGFR <= 50 ml/min
-PaO2 >= 70 mmHg
-ECG: no severe abnormalities
f) No prior chemotherapy or no prior irradiation
g) Written informed concent

Key exclusion criteria

a) with active gastrointestinal hemorrhage
b) with clinically important infection
c) with severe complicatons (heart failure, renal failure, liver failure, uncontrollable diabetes, etc.)
d) with another active malignant tumors
e) pregnant and/or lactating women
f) judged not to understand the trial explanation
g) judged to be unfit to participate in this study by investigater

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name YAMASHITA Hideomi

Organization

The University of Tokyo Hospital

Division name

The department of Radiology

Zip code


Address

7-3-1, Hongo, Bunkyo-ku, Tokyo

TEL

+81-3-5800-8667

Email

yamachan07291973@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name KIRITOSHI Tomoki

Organization

The University of Tokyo Hospital

Division name

The department of Radiology

Zip code


Address

7-3-1, Hongo, Bunkyo-ku, Tokyo

TEL

+81-3-5800-8667

Homepage URL

http://www.u-tokyo-rad.jp/2015/10/30164804.html

Email

kiritoshit-rad@h.u-tokyo.ac.jp


Sponsor or person

Institute

The University of Tokyo Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

東京大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2015 Year 12 Month 17 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

Enrolling by invitation

Date of protocol fixation

2015 Year 11 Month 19 Day

Date of IRB


Anticipated trial start date

2015 Year 12 Month 14 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 12 Month 04 Day

Last modified on

2018 Year 12 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023167


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name