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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020075
Receipt No. 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

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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
Institute The University of Tokyo Hospital
Institute
Department

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
URL(English) https://upload.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


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