UMIN-CTR Clinical Trial

Basic information
Public title	Randomized controlled trial of esophagectomy versus chemoradiotherapy in patients with clinical stage I esophageal carcinoma JCOG0502
Acronym	Randomized controlled trial of esophagectomy versus chemoradiotherapy in patients with clinical stage I esophageal carcinoma JCOG0502
Scientific Title	Randomized controlled trial of esophagectomy versus chemoradiotherapy in patients with clinical stage I esophageal carcinoma JCOG0502
Scientific Title:Acronym	Randomized controlled trial of esophagectomy versus chemoradiotherapy in patients with clinical stage I esophageal carcinoma JCOG0502
Region	Japan

Condition
Condition	Esophageal Carcinoma
Classification by specialty	Gastroenterology Gastrointestinal surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To verify the non-inferiority of survival benefit of chemoradiation compared to surgery in stage I esophageal carcinoma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Overall Survival
Key secondary outcomes	Complete Response Rate, Adverse Events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
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:Esophagectomy with D2 (or more) lymph node desection
Interventions/Control_2	B:Chemoradiation 5FU 700mg/m2/day civ Day1-4, 29-32 CDDP 70mg/m2/day div Day1, 29 radiation 60Gy/30fr/6w
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 esophageal cancer (squamous cell carcinoma, adenosquamous cell carcinoma, besaloid carcinoma) (2)all lesions are localized in thoracic esophagus. (3)The depth of main lesion is endoscopically diagnosed submucosa. (4)No lymphnode metastasis and no distant metastasis. (5)No prior chemotherapy and/or radiotherapy. Only curative endoscopic mucosal resection is allowed. (6)ages 20 years-75years (7)PS(ECOG) 0-1 (8)Normal organic function. (9)oral or written informed consent obtained before randomization
Key exclusion criteria	(1)synchronous or metachronous (within 5 years) malignancy (2)Pregnant or lactating (3)psychiatric medication (3)Systemic administration of steroids (4)HBsAg positive (5)Use of insulin injection therapy or uncontrolled diabetes mellitus (6)History of acute myocardial infarction (within 3 months) or unstable angina (7)Severe complecations (COPD, pulmonary fibrillation, heart failure etc.) (8)active bacterial infection
Target sample size	114

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroyasu Igaki
Organization	National Cancer Center Hospital
Division name	Surgical Oncology
Zip code
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL	03-3542-2511
Email

Public contact
Name of contact person	1st name Middle name Last name Ken Kato
Organization	JCOG0502 Coordinating Office
Division name	Gastrointestinal Oncology, National Cancer Center Hospital
Zip code
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL	03-3542-2511
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)

IRB Contact (For public release)
Organization
Address
Tel
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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） 栃木県立がんセンター（栃木県） 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） 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） 東京医科歯科大学（東京都） 虎の門病院（東京都） 東海大学医学部（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） 富山大学附属病院（富山県） 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） 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） 広島大学病院（広島県） 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	2006 Year 12 Month 20 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	2006 Year 11 Month 06 Day
Date of IRB	2006 Year 12 Month 08 Day
Anticipated trial start date	2006 Year 12 Month 01 Day
Last follow-up date	2017 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

This study is randomized phaseIII trial which have two arms (group A:Surgery + group B:chemoradiation = 114pts). Even if the patients refuse to be enrolled to the randomized part, patients can be enrolled to the non-randomized part (group C: non-randomized Surgery = 156pts, group D: non-randomized chemoradiation = 156pts). We also verify the non-inferiority of survival benefit between group C and D.

Management information
Registered date	2006 Year 12 Month 20 Day
Last modified on	2022 Year 08 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000668