UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II Randomized Radiation Dose Study of Concurrent Chemoradiotherapy With S-1 Plus Nedaplatin for Esophageal Cancer
Title of the study (Brief title)	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	YAMASHITA Hideomi
Organization	The University of Tokyo Hospital
Division name	The department of Radiology
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	+81-3-5800-8667
Email	yamachan07291973@yahoo.co.jp

Public contact
Name of contact person	KIRITOSHI Tomoki
Organization	The University of Tokyo Hospital
Division name	The department of Radiology
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 11 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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