UMIN-CTR Clinical Trial

Basic information
Public title	A randomized controlled phase III comparing CF versus DCF versus CF-RT as neoadjuvant treatment for locally advanced esophageal cancer (JCOG1109, NExT study)
Acronym	A randomized controlled phase III comparing CF versus DCF versus CF-RT as neoadjuvant treatment for locally advanced esophageal cancer (JCOG1109, NExT study)
Scientific Title	A randomized controlled phase III comparing CF versus DCF versus CF-RT as neoadjuvant treatment for locally advanced esophageal cancer (JCOG1109, NExT study)
Scientific Title:Acronym	A randomized controlled phase III comparing CF versus DCF versus CF-RT as neoadjuvant treatment for locally advanced esophageal cancer (JCOG1109, NExT study)
Region	Japan

Condition
Condition	clinical stage IB/II/III thoracic esophageal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery Radiology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the superiority of preoperative chemotherapy with DCF (docetaxel/cisplatin/5-FU) and preoperative chemoradiotherapy with CF (cisplatin/5-FU) over preoperative chemotherapy with CF for clinical stage IB/II/III (excluding T4) thoracic esophageal cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Overall Survival
Key secondary outcomes	Progression-free survival, R0 resection rate, response rate, pathological complete response rate, adverse events during preoperative therapy, surgical morbidity, late toxicity, serious 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	3
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment Maneuver
Interventions/Control_1	A: Two courses of preopeartive chemotherapy with cisplatin (80 mg/m2/day, day 1) and 5-FU (800 mg/m2/day, day 1-5) repeated every 3 weeks followed by surgery
Interventions/Control_2	B: Three courses of preoperative chemotherapy with docetaxel (70 mg/m2/day, day 1), cisplatin (70 mg/m2/day, day1) and 5-FU (750 mg/m2/day, day 1-5) repeated every 3 weeks followed by surgery
Interventions/Control_3	C: Two courses of preoperative chemoradiotherapy (41.4Gy/23fr) with cisplatin (75 mg/m2/day, day 1) and 5-FU (1000 mg/m2/day, day 1-4) repeated every 4 weeks followed by surgery
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 2) All lesion located in the thoracic esophagus 3) Clinical stage IB, II, III (excluding T4) based on the 7th UICC-TNM classification 4) Aged 20 to 75 years old 5) ECOG performance status of 0 or 1 6) Measurable lesions not required 7) No prior therapy against esophageal cancer except for complete resection by EMR/ESD with either pT1a-LPM(M2)/T1a-MM(M3) disease or pT1a-MM(M3) disease without vascular infiltration 8) No prior chemotherapy, radiotherapy or hormonal therapy against any cancers except for hormonal therapy for prostate cancer with more than 5 years of disease-free interval 9) Adequate organ functions 10) R0 esophagectomy is judged as possible by open (or laparoscopic) thoracotomy and laparotomy 11) Written informed consent
Key exclusion criteria	1) Simultaneous or metachronous (within 5 years) double cancers, except for intramucosal tumor curatively resected by local therapy 2) Active infection requiring systemic therapy 3) Positive HBs antigen, HCV antibody or HIV antibody 4) Pregnant or lactating women or women of childbearing potential 5) Psychiatric disease 6) Patients requiring systemic steroids medication 7) Requiring continuous administration of flucytosine, phenytoin or warfarin potassium 8) Iodine hypersensitivity 9) Hypersensitivity for docetaxel, cisplatin or polysorbate 80 containing drug 10) Diabetes mellitus with HbA1c of 6.5%(JDS),6.9%(NGSP)or higher 11) Severe emphysema or pulmonary fibrosis 12) Poorly controlled hypertension 13) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months.
Target sample size	600

Research contact person
Name of lead principal investigator	1st name Middle name Last name Ken Kato
Organization	National Cancer Center Hospital
Division name	Gastrointestinal Oncology
Zip code
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL	03-3542-2511(2369)
Email	kenkato@ncc.go.jp

Public contact
Name of contact person	1st name Middle name Last name Ken Kato
Organization	JCOG1109 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(2369)
Homepage URL	http://www.jcog.jp/
Email	JCOG_sir@ml.jcog.jp

Sponsor
Institute	Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization	National Cancer Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
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IRB Contact (For public release)
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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） 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） 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） がん研究会有明病院（東京都） 虎の門病院（東京都） 東海大学医学部（神奈川県） 神奈川県立病院機構神奈川県立がんセンター（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） 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） 名古屋大学医学部（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） 熊本大学医学部附属病院（熊本県） 大分大学医学部附属病院（大分県）

Other administrative information
Date of disclosure of the study information	2012 Year 12 Month 05 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
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Results
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Results Delayed
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Baseline Characteristics
Participant flow
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IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 11 Month 01 Day
Date of IRB	2012 Year 11 Month 22 Day
Anticipated trial start date	2012 Year 12 Month 05 Day
Last follow-up date	2024 Year 03 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 12 Month 05 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=R000011013