UMIN-CTR Clinical Trial

Basic information
Public title	Phase I Dose-Escalation Study of Intensity-modulated Radiation Therapy in Patients with Locally Advanced Unresectable Esophageal Cancer
Acronym	Phase I Dose-Escalation Study of Intensity-modulated Radiation Therapy in Patients with Locally Advanced Unresectable Esophageal Cancer
Scientific Title	Phase I Dose-Escalation Study of Intensity-modulated Radiation Therapy in Patients with Locally Advanced Unresectable Esophageal Cancer
Scientific Title:Acronym	Phase I Dose-Escalation Study of Intensity-modulated Radiation Therapy in Patients with Locally Advanced Unresectable Esophageal Cancer
Region	Japan

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

Objectives
Narrative objectives1	To estimate the maximum tolerated dose and to determine the recommended dose of intensity-modulated radiation therapy for locally advanced unresectable thoracic esophageal cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	incidence of (1) Grade 3 or more esophagitis, (2) Grade 2 or more radiation pneumonitis, (3) Grade 2 or more conduction disorder/pericardial effusion/pericarditis/acute coronary syndrome within 90 days after intensity-modulated radiation therapy and (4) more than 60 days of treatment duration to finish a radiation therapy due to adverse events
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 (700 mg/m2, day 1-4, day 29-32), cisplatin (70 mg/m2, day 1, 29) and intensity-modulated radiation therapy (66-72 Gy/30 fr: 66 Gy/30 fr at level 1, 69 Gy/30 fr at level 2 and 72 Gy/30 fr at level 3), followed by adittional two courses chemotherapy with 5-FU (800 mg/m2, day 1-5) plus cisplatin (80 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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma located in the thoracic esophagus 2) Clinical stage IIIC or IV with supraclavicular lymph node metastasis i)Primary tumor invasion depth T4 ii)Metastatic regional lymph node(s) invasion to adjacent organ 3) No esophageal fistula 4) No aortic invasion 5) Aged 20 to 75 years old 6) ECOG Performance status 0 or 1 7) Adequate organ functions 8) 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 8) Uncontrolled 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) With a history of cerebrovascular disorder within 6 months 12) Connective tissue disease 13) History of radiation therapy to chest 14) History of surgery for esophageal cancer
Target sample size	18

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Masahiro Hiraoka
Organization	Graduate School of Medicine and Faculty of Medicine Kyoto University
Division name	Department of Radiation Oncology and Image-Applied Therapy
Zip code
Address	54, Sho-goinn, Kawaharacho, Sakyo-ku, Kyoto, Kyoto
TEL	075-751-3419
Email	hiraok@kuhp.kyoto-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Katsuyuki Sakanaka
Organization	Graduate School of Medicine and Faculty of Medicine Kyoto University
Division name	Department of Radiation Oncology and Image-Applied Therapy
Zip code
Address	54, Sho-goinn, Kawaharacho, Sakyo-ku, Kyoto, Kyoto
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 and Faculty of Medicine Kyoto University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information	2014 Year 10 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	Completed
Date of protocol fixation	2014 Year 09 Month 24 Day
Date of IRB	2014 Year 10 Month 10 Day
Anticipated trial start date	2014 Year 10 Month 10 Day
Last follow-up date	2018 Year 12 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	2014 Year 10 Month 01 Day
Last modified on	2019 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017795