UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study of intensity modulated radiation therapy (IMRT) with chemotherapy for cervical esophageal cancer (JROSG12-1)
Title of the study (Brief title)	IMRT for cervical esophageal cancer (JROSG12-1)
Region	Japan

Condition
Condition	cervical esophageal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery Oto-rhino-laryngology Radiology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and the safety of chemoradiotherapy with Intensity Modulated Radiation Therapy (IMRT) in patients with cervical esophageal cancer (clinical stage II-III, or IV with supraclavicular LN metastasis, UICC 7th edition)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	3 year overall survival
Key secondary outcomes	3 year progeression-free survival, 3y esophagus preservation rate, 3y larynx preservation rate, early and late adverse event rates

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Concurrent chemoradiotherapy with SIB-IMRT (60Gy (prophylactin LN region: 48Gy)/30fr.) and two cycles of chemotherapy (5-FU 700 mg/m2, day 1-4, CDDP 70 mg/m2, day1, q4w) follwed by two cycles of adjuvant chemotherapy with 5-FU (700 mg/m2, day 1-5) plus cisplatin (70 mg/m2, day 1) repeated every 4 weeks.
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	i) cervical esophageal cancer with pathologically proven squamous cell carcinoma or adenosquamous cell carcinoma; ii) Clinical stage II-III or IV with supraclavicular LN metastasis (UICC 7th edition, 2009) ; iii) Aged 20 to 75 years old; iv) ECOG PS of 0 to 2; v) No prior chemotherapy against any malignancies; vi) No prior radiotherapy against head and neck or chest region; vii) Screening and diagnosis by an otorhinolaryngologist; viii) Sufficeient organ functions; ix) Written informed consent.
Key exclusion criteria	i) Simultaneous or metachronous (within 5 years) double cancers; ii) Systemic infections disease; iii) Body temperature of 38C or higher; iv) Women during pregnancy or breast-feeding; v) Psychiatric disease and/or depression; vi) Continuous systemic steroids medication; vii) HBs antigen positive; viii) Uncontrollable diabetes mellitus; ix) Uncontrollable hypertension; x) Myocardial infarction within 6 months or unstable angina pectoris; xi) Serious complications (interstitial pneumonia, pulmonary fibrosis, COPD, heart failure, etc.); xii) cerebrovasucular disease within 6 months; xiii) Histoty of collagen diseases; xiv) History of surgery of esophagus
Target sample size	44

Research contact person
Name of lead principal investigator	Yasumasa Nishimura
Organization	Medical Faculty, Kinki University.
Division name	Department of Radiation Oncology
Address	377-2, Ono-higashi, Osaka-Sayama, Osaka, 589-8511, Japan
TEL	072-368-2388
Email	ynishii@med.kindai.ca.jp

Public contact
Name of contact person	Satoshi Itasaka
Organization	JROSG 12-1 Coordinating Office
Division name	Department of Radiation Oncology, Kurashiki Central Hospital
Address	1-1-1 Miwa, Kurashiki, Okayama, 710-8602, Japan
TEL	086-422-0210
Homepage URL	http://www.jrosg.jp/protocol/protocol_list.html
Email	sitasaka@kchnet.or.jp

Sponsor
Institute	Japanese Radiation Oncology Study Group(JROSG)
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	北海道大学病院（北海道） 札幌医科大学（北海道） 東北大学病院（宮城県） 国立がん研究センター東病院（千葉県） 国立がん研究センター中央病院（東京都） 埼玉県立がんセンター（埼玉県） 神奈川県立がんセンター（神奈川県） 群馬大学病院（群馬県） 愛知県がんセンター中央病院（愛知県） 京都大学医学部附属病院（京都府） 京都府立大学（京都府） 近畿大学医学部（大阪府） 大阪府立病院機構大阪府立成人病センター（大阪府） 広島大学病院（広島県） 兵庫県立がんセンター（兵庫県） 滋賀県立成人病センター（滋賀県） 倉敷中央病院(岡山県） 香川大学（香川県）

Other administrative information
Date of disclosure of the study information	2013 Year 01 Month 28 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 01 Month 15 Day
Anticipated trial start date	2013 Year 02 Month 16 Day
Last follow-up date	2020 Year 08 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	2013 Year 01 Month 28 Day
Last modified on	2018 Year 08 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011462