UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II randomized controlled trial comparing perioperative mFOLFOXIRI with perioperative chemoradiotherapy for locally advanced rectal cancer.
Title of the study (Brief title)	A phase II randomized controlled trial comparing perioperative mFOLFOXIRI with perioperative chemoradiotherapy for locally advanced rectal cancer.
Region	Japan

Condition
Condition	Rectal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Safety, Efficacy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	RFS:3 years relapse free survival
Key secondary outcomes	Response rate, Proportion of patients with R0 resection, Pathological response, 3 years progression free survival, 3 years overall survival, Incidence of adverse events, Proportion of operative complication, Proportion of anus-preservation without stoma, Evaluation of anal function, Evaluation of bladder function

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	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	preoperative FOLFOXIRI+surgery
Interventions/Control_2	preoperative chemoradiotherapy+surgery
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. Pathologically proven adenocarcinoma. 2. Primary tumor located at Rectosigmoid, Upper rectum, Lower rectum, and Anal canal.The lower border of the tumor located between the peritoneal reflection and the anal verge. 3. cT3and cT4a tumor on contrast-enhanced CT or MRI 4. Lateral lymph nodes without 7mm and more in short axis diameter on contrast-enhanced CT or MRI data of 5mm-thickness slices (cN0-cN2) . 5. No distant metastasis on contrast-enhanced CT or MRI (cM0) 6. Aged 20 to 74 years old 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 8. Adequate organ function as evidenced by the following laboratory studies within 14 days prior to enrollment 1) Neutrophil count >= 1,500 /mm3 2) Platelet count >= 100,000 /mm3 3) Hemoglobin >= 9.0 g/dL 4) T.Bil =< 2.0 mg/dL 5) AST =< 100 IU/L, ALT =< 100 IU/L 6) Cr =< 1.5 mg/dL 9. Written informed consent
Key exclusion criteria	1. Currently treated with systemic steroids or immunosuppressive agent 2. Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma 3. Infectious disease to be treated 4. Positive for HBs antigen 5. Uncontrollable hypertension, Uncontrollable diabetes mellitus, Uncontrollable arrhythmia, and severe clinical problem 6. Grade 1 or more peripheral neuropathy 7. Women during pregnancy, possible pregnancy or breast-feeding 8. Severe mental disease 9. Attending physician determines that the case was inappropriate as the subject of this study
Target sample size	34

Research contact person
Name of lead principal investigator	Kazuhisa Uchiyama
Organization	Osaka Medical College Hospital
Division name	Department of general and gastroenterological surgery
Address	2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
TEL	072-683-1221
Email	uchi@poh.osaka-med.ac.jp

Public contact
Name of contact person	Keitarou Tanaka
Organization	Osaka Medical College Hospital
Division name	Department of general and gastroenterological surgery
Address	2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
TEL	072-683-1221
Homepage URL
Email	sur036@poh.osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College Hospital
Institute
Department

Funding Source
Organization	Osaka Medical College Hospital
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	大阪医科大学附属病院

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 06 Day
Anticipated trial start date	2015 Year 08 Month 20 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	2015 Year 08 Month 10 Day
Last modified on	2018 Year 02 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021553