UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032254 |
|---|---|
| Receipt number | 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 23:58:39 |
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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
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
aishibe@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036781
