UMIN-CTR Clinical Trial

Basic information
Public title	A pilot study of definitive chemoradiotherapy using involved-field intensity-modulatd radiation therapy for patients with clinical stage IB-IIIC (non T4) esophageal carcinoma
Acronym	A pilot study of definitive chemoradiotherapy using involved-field intensity-modulatd radiation therapy for patients with clinical stage IB-IIIC (non T4) esophageal carcinoma
Scientific Title	A pilot study of definitive chemoradiotherapy using involved-field intensity-modulatd radiation therapy for patients with clinical stage IB-IIIC (non T4) esophageal carcinoma
Scientific Title:Acronym	A pilot study of definitive chemoradiotherapy using involved-field intensity-modulatd radiation therapy for patients with clinical stage IB-IIIC (non T4) esophageal carcinoma
Region	Japan

Condition
Condition	Esophageal neoplasm
Classification by specialty	Gastroenterology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of definitive chemoradiotherapy using involved-field intensity-modulated radiation therapy for clinical stage IB-IIIC (non T4) esophageal carcinoma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Complete response rate
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	Medicine
Interventions/Control_1	Chemoradiotherapy consists of 5-FU (1,000 mg/m2, day 1-4, day 29-32), cisplatin (75 mg/m2, day 1, 29) and involved-field intensity-modulated radiation therapy (50.4 Gy/28 fr), followed by adittional two courses chemotherapy with 5-FU (1,000 mg/m2, day 1-4) plus cisplatin (75 mg/m2, day 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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma in thoracic esophagus 2)Patients refuse to receive or are unfit for a surgical resection 3) Clinical stage IB-IIIC except for cT4 (TNM 7th) 4) Aged 20 to 80 years old 5) ECOG Performance status 0 or 1 6) Adequate organ functions 7) Written informed consent
Key exclusion criteria	1) Simultaneous or metachronous (within 5 years) double cancers , with the exception of intramucosal tumor curable with local therapy 2) Active infection requiring systemic therapy 3) Fever over 38 degrees Celsius 4) Pregnant or lactating women or women of childbearing potential 5) Psychosis 6) Patients requiring systemic steroids medication 7) Serum HBs antigen positive within 1 year 8) Poorly controlled diabetes mellitus 9) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months. 10) Interstitial pneumonia, fibroid lung, or severe emphysema 11) History of cerebrovascular disorder within 6 months 12) Connective tissue disease 13) History of a surgical resection for esophagus
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Masahiro Middle name Last name Hiraoka
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Radiation Oncology and Image-Applied Therapy
Zip code	6068507
Address	54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Kyoto
TEL	075-751-3762
Email	hiraok@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Katsuyuki Middle name Last name Sakanaka
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Radiation Oncology and Image-Applied Therapy
Zip code	6068371
Address	Sakyo-ku,
TEL	075-751-3762
Homepage URL
Email	sakanaka@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel	(tel)075-753-4680
Email	ethcom@kuhp.kyoto-u.ac.jp

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	2015 Year 07 Month 23 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	Completed
Date of protocol fixation	2017 Year 06 Month 24 Day
Date of IRB	2015 Year 06 Month 24 Day
Anticipated trial start date	2017 Year 06 Month 24 Day
Last follow-up date	2018 Year 06 Month 23 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 05 Month 25 Day
Last modified on	2019 Year 11 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020474