UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Randomized PhaseII/III Study of Concurrent Chemoradiotherapy with Low Dose Cisplatin plus 5-FU versus Concurrent Chemoraiotherapy with Standard Dose Cisplatin plus 5-FU for Locally Advanced Unresetable Esophageal Cancer in the Thorax.(JCOG0303)
Title of the study (Brief title)	A Randomized PhaseII/III Study of Concurrent Chemoradiotherapy with Low Dose Cisplatin plus 5-FU versus Concurrent Chemoraiotherapy with Standard Dose Cisplatin plus 5-FU for Locally Advanced Unresetable Esophageal Cancer in the Thorax.(JCOG0303)
Region	Japan

Condition
Condition	Locally advanced unresectable esophageal cancer in the thorax
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safty of concurrent chemoradiotherapy of low dose cisplatin plus 5-FU compared with concurrent chemoradiotherapy of standard dose cisplatin plus 5-FU for locally advanced unresectable thoracic esophageal cancer without distant metastasis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II,III

Assessment
Primary outcomes	overall survival
Key secondary outcomes	complete response rate, treatment completion rate, treatment completion rate by PS, adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	A: Standard Dose concurrent chemoradiotherapy (RT: 60Gy/30fr/6w; Cisplatin 70mg/m2 on day 1,29; 5-FU 700mg/m2 on days 1-4, 29-32)
Interventions/Control_2	B:Low Dose concurrent chemoradiotherapy (RT: 60Gy/30fr /6w; Cisplatin 4mg/m2 and 5-FU 200mg/m2, 5 days every week, repeatedly for 6 weeks.)
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)Esophageal cancer histologically proven by GIF biopsy (squamons cell carcinoma, adenosquamous carcinoma, basaloid carcinoma) 2)Location of the lesion confirmed by esophagogram i)Lesion mainly located in the thoracic esophagus ii)Both primary lesion and intramural matastasis do not invade beyond GE junction 3)Radiotherapist determines before registration that irradiation up to 60 Gy can be completed safely. 4)Tumors are judged unresectable by CT and palpation for the following reason. i)Primary tumor invasion depth T4 ii)Metastatic regional lymph node(s) invasion to adjacent organ. iii)Metastatic lymph node(s) such as fixed supraclavicular or coeliac lymph node(s) provided according to the location of main tumor. 5)No distant organ metastasis. 6)Neither esophago-airway fistula nor esophago-mediastinal fistula 7)Neither Radiotherapy nor chemotherapy against any cancers. No previous therapy except EMR against esophageal cancer 8)Age from 20 to 75 years 9)Performance status of 0-2 10)Adequate organ function 11)Written informed consent
Key exclusion criteria	1)Simultaneous or metachronous (within 5 years) double cancers 2)Pregnancy or lactation 3)Serious psychiatric illness 4)Steroid treatment 5)HBs antigen positive 6)Uncontrollable diabetes 7)Myocaedial infarcion within 3 months 8)Serious comorbidity 9)Active bacterial or fungous infection
Target sample size	364

Research contact person
Name of lead principal investigator	Masayuki Shinoda
Organization	Aichi Cancer Center Hospital
Division name	Department of Thoracic Surgery
Address	1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan
TEL	052-762-6111
Email

Public contact
Name of contact person	Masayuki Shinoda
Organization	JCOG0303 Coordinating Office
Division name	Department of Thoracic Surgery, Aichi Cancer Center Hospital
Address	1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan
TEL	052-762-6111
Homepage URL	http://www.jcog.jp/
Email	JCOG_sir@ml.jcog.jp

Sponsor
Institute	Japan Clinical Oncology Group(JCOG)
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

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） 岩手医科大学（岩手県） 東北大学病院（宮城県） 山形県立中央病院（山形県） 茨城県立中央病院・茨城県地域がんセンター（茨城県） 栃木県立がんセンター（栃木県） 埼玉県立がんセンター（埼玉県） 国立がん研究センター東病院（千葉県） 千葉県がんセンター（千葉県） 千葉大学医学部（千葉県） 総合病院国保旭中央病院（千葉県） 東京歯科大学市川総合病院（千葉県） 国立がん研究センター中央病院（東京都） 東京女子医科大学（東京都） 国立病院機構東京医療センター（東京都） 慶應義塾大学病院（東京都） 昭和大学病院（東京都） 東京医科歯科大学（東京都） 癌研究会有明病院（東京都） 虎の門病院（東京都） 東海大学医学部（神奈川県） 横浜市立市民病院（神奈川県） 新潟県立がんセンター新潟病院（新潟県） 新潟大学医歯学総合病院（新潟県） 佐久総合病院（長野県） 静岡県立総合病院（静岡県） 静岡県立静岡がんセンター（静岡県） 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） 大阪府立病院機構大阪府立成人病センター（大阪府） 国立病院機構大阪医療センター（大阪府） 大阪市立総合医療センター（大阪府） 大阪医科大学（大阪府） 神戸大学医学部（兵庫県） 兵庫県立がんセンター（兵庫県） 広島市立安佐市民病院（広島県） 国立病院機構四国がんセンター（愛媛県） 高知医療センター（高知県） 国立病院機構九州がんセンター（福岡県） 久留米大学医学部（福岡県） 九州大学病院（福岡県）

Other administrative information
Date of disclosure of the study information	2007 Year 10 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2004 Year 02 Month 20 Day
Anticipated trial start date	2004 Year 04 Month 01 Day
Last follow-up date	2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.ncbi.nlm.nih.gov/pubmed/25640628
Results	See the datails via "URL releasing results" above. Also the details can be seen in the JCOG website: http://www.jcog.jp/en/trials/index.html
Other related information

Management information
Registered date	2007 Year 10 Month 23 Day
Last modified on	2017 Year 11 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001025