UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The feasibility and efficacy of neoadjuvant FOLFOXIRI followed by laparoscopic surgery for locally advaned rectal cancer: A phase II study
Title of the study (Brief title)	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	Kazuhisa Uchiyama
Organization	Osaka Medical College Hospital
Division name	General and Gastrointestinal Surgery
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	Tetsuji Terasawa
Organization	Osaka Medical College Hospital
Division name	Chemotherapy Center
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000030514