UMIN-CTR Clinical Trial

Basic information
Public title	PhaseIII trial of neoadjuvant chemotherapy using CAPEOX with optional local treatment for locally advanced rectal cancer
Acronym	NEXT trial
Scientific Title	PhaseIII trial of neoadjuvant chemotherapy using CAPEOX with optional local treatment for locally advanced rectal cancer
Scientific Title:Acronym	NEXT trial
Region	Japan

Condition
Condition	Locally advanced rectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of neoadjuvant chemotherapy using CAPEOX with optional local treatment for locally advanced rectal cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II,III

Assessment
Primary outcomes	5-year relapse free survival
Key secondary outcomes	CRM positive rate, CRT rate, LLND rate, R0 rate, morbidity rate, response rate of neoadjuvant chemotherapy/chemoradiotherapy and completion rate, 5-year local recurrence rate, 5-year overall survival

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	Preoperative chemoradiation (Capecitabine + Radiation 50.4Gy) + Surgery(optional LLND)
Interventions/Control_2	Neoadjuvant chemotherapy (CAPEOX 4 course)+optional preoperative chemoradiation + Srugery(optional LLND)
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Age 20-80 2) Adenocarcinoma proven histologically 3) Lower edge of rectal cancer is less than 10cm from anal verge 4) ECOG Performance Status(PS)0-1 5) Clinical StageII/III (excluded cT4b) 6) Resectable rectal cancer. 7) No prior chemotherapy, radiotherapy and rectal surgery without local resection. 8) Adequate organ function to performed surgery. 1. WBC>=3,000/mm3 2. Neutrophils >=1,500/mm3 3. Hb>=8.0g/dl 4. Plt >=100,000/mm3 5. GOT <=100IU/L 6. GPT <=100IU/L 7. T-Bil <= 2.0mg/dl 8. Cr <= 1.5mg/dl 9) Written informed consent
Key exclusion criteria	1) Synchronous or metachronous (within 5 years)malignancies other than carcinoma in situ or mucosal carcinoma 2) Bowel obstruction 3) Uncontrollable diabetes mellitus (HbA1c>=8.0) 4) Unstable ungina pectoris 5) Liver cirrhosis,Liver failure 6) Interstitial pneumonia 7) Pregnant or possibly pregnant women 8) Past history of using 5-FU, oxaliplatin based chemotherapy 9) Past history of radiotherapy 10) Other conditions judged ineligible by physician
Target sample size	440

Research contact person
Last name of lead principal investigator	1st name Atsushi Middle name Last name Ishibe
Organization	Yokohama City University
Division name	Dept. of Gastroenterological surgery
Zip code	236-0004
Address	3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL	045-787-2650
Email	aishibe@yokohama-cu.ac.jp

Public contact
1st name of contact person	1st name Atsushi Middle name Last name Ishibe
Organization	Yokohama City University
Division name	Dept. of Gastroentelorogical Surgery
Zip code	236-0004
Address	3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL	045-787-2650
Homepage URL
Email	aishibe@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	Yokohama Clinical Oncology Group(YCOG)
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokohama City University
Address	1-1-1 Fukuura, Kanazawa-ku
Tel	045-370-7627
Email	onodera@yokohama-cu.ac.jp

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	2018 Year 08 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	Preinitiation
Date of protocol fixation	2018 Year 04 Month 05 Day
Date of IRB
Anticipated trial start date	2019 Year 08 Month 01 Day
Last follow-up date	2027 Year 07 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	2018 Year 04 Month 15 Day
Last modified on	2019 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036781