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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026575
Receipt No. R000030514
Scientific Title The feasibility and efficacy of neoadjuvant FOLFOXIRI followed by laparoscopic surgery for locally advaned rectal cancer: A phase II study
Date of disclosure of the study information 2017/03/16
Last modified on 2018/03/16

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Basic information
Public title The feasibility and efficacy of neoadjuvant FOLFOXIRI followed by laparoscopic surgery for locally advaned rectal cancer: A phase II study
Acronym nacFOLFOXIRI followed by LAP(NFL)
Scientific Title The feasibility and efficacy of neoadjuvant FOLFOXIRI followed by laparoscopic surgery for locally advaned rectal cancer: A phase II study
Scientific Title:Acronym nacFOLFOXIRI followed by LAP(NFL)
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate theThe feasibility and efficacy of neoadjuvant FOLFOXIRI followed by laparoscopic surgery for locally advaned rectal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Disease control rate: DCR
Key secondary outcomes Response Rate:RR,Progression free survival:PFS,Overall survival:OS,Time to Treatment Failure:TTF,Safety(the rate of Grade3/4toxicity)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 chemotherapy : FOLFOXIRI
Interventions/Control_2
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
74 years-old >=
Gender Male and Female
Key inclusion criteria 1)Histologically confirmed CRC that is not
a candidate for curative surginal resection
2)the lower edge of tumor location is Rb-P
3)diagnosed as cT2N1-3N0 or cT3/4N0-3M0
4)there is no lateral lympha node metastasis
5)Age 20-74
6)Psrformance status:0-1
7)Adequate organ functiont
8)Written informed consent prior to sutudy-specific screening procedure
Key exclusion criteria 1)Requires continuous treatment with systtematic steroids
2)History of other malignancy with a disease-free interval<1years(other than curatively treated cutaneous basal cell carcinoma,curatively treated carcinoma in situ of the cervix,and gastroenterological cancer confirmed to be cured by endoscopic mucosal resection)
3)Active infections Pr
evious palliative radiation therapy for bone metastasis or brain metastasis within 2 weeks
4)HBs antigen positive
5)Uncontrolled diarrhea,unstable angia,Uncontrolled diabetes mellitus
6)Serious complications
7)grade1 of neuropathy
8)Pregnant or lactating females,and males and fenales unwilling to use contraception
9)Psychiatric disability that would preclude study compliance
10)Otherwise determined by the investigator to be unsuitable for participation in the study
Target sample size 58

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhisa Uchiyama
Organization Osaka Medical College Hospital
Division name General and Gastrointestinal Surgery
Zip code
Address 2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
TEL 072-683-1211
Email uchi@osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuji Terasawa
Organization Osaka Medical College Hospital
Division name Chemotherapy Center
Zip code
Address 2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
TEL 072-683-1211
Homepage URL
Email terasawat@osaka-med.ac.jp

Sponsor
Institute Osaka Medical College Hospital
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 03 Month 16 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
2017 Year 03 Month 17 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 16 Day
Last modified on
2018 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030514

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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