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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032254
Receipt No. R000036781
Scientific Title PhaseIII trial of neoadjuvant chemotherapy using CAPEOX with optional local treatment for locally advanced rectal cancer
Date of disclosure of the study information 2018/08/01
Last modified on 2019/04/17

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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
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
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/ctr_e/ctr_view.cgi?recptno=R000036781

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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