UMIN-CTR Clinical Trial

Basic information
Public title	A Phase II/III Randomized multicenter Trial of Intersphincteric resection (ISR) with or without Preoperative Chemotherapy for very low-lying Rectal Cancer
Acronym	Neo-adjuvant chemotherapy for Intersphincteric resection (ISR) in Low Rectal Cancers NAIR. Study
Scientific Title	A Phase II/III Randomized multicenter Trial of Intersphincteric resection (ISR) with or without Preoperative Chemotherapy for very low-lying Rectal Cancer
Scientific Title:Acronym	Neo-adjuvant chemotherapy for Intersphincteric resection (ISR) in Low Rectal Cancers NAIR. Study
Region	Japan

Condition
Condition	Very Low Rectal Cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Improvement of disease free survival including local recurrence rate
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II,III

Assessment
Primary outcomes	PhaseII : Evaluation of safety in all treatment course ( operation, chemotherapy) PhaseIII : Disease free survival at three years
Key secondary outcomes	Overall survival at three years, Rate of curative operation. Postoperative anal function and QOL, Tumor response to neoadjuvant chemotherapy, adverse events in chemotherapy,

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	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	A : ISR plus adjuvant chemotherapy
Interventions/Control_2	B : ISR with neoadjuvant chemotherapy plus adjuvant chemotherapy
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Primary rectal cancer located within 5cm from the anal verge, or located within 3cm from the dentate line. 2) Pathological proven adenocarcinoma. 3) Clinical T3 N any M0 4) No invasion to the external sphincter by preoperative imaging diagnosis 5) Possible to be curative resection 6) Aged 20 to 75 years old 7) Enough organ functions i. WBC count > 3,000/mm3 ii. Platelet count > 100,000/ mm3 iii. Hemoglobin > 8.0 g/dl iv. AST < 100 IU/L v. ALT < 100IU/L vi. T.Bil < 2.0mg/dl vii. Cr < 1.5mg/dl viii. PT Consumption > 50% 8) PS of 0 or 1 9) Without previous radiotherapy and chemotherapy 10) Written informed consent
Key exclusion criteria	1) Patients with request of abdominoperineal resection (APR) 2) Patients with impossibility for ISR 3) Patients with poor anal function preoperatively 4) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in site or mucosal carcinoma 5) Patients with serious diseases as follows i. Uncontrollable diabetes mellitus ii. Uncontrollable hypertension iii. Interstitial pneumonia, pulmonary fibrosis, or severe emphysema 6) Chronic active hepatitis type B. Positive for HCV 7) Episodes of blood transfusion within the post 14 days 8) Patients with severe mental disease 9) Cannot agree on this study 10) Unsuitable patients for this study
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Masaaki Middle name Last name Ito
Organization	National Cancer Center Hospital East
Division name	Colorectal and Pelvic Surgery
Zip code	277-8577
Address	6-5-1, Kashiwanoha, Kashiwa, 277-8577, Japan
TEL	04-7133-1111
Email	maito@east.ncc.go.jp

Public contact
Name of contact person	1st name Yuichiro Middle name Last name Tsukada
Organization	National Cancer Center Hospital East
Division name	Colorectal and Pelvic Surgery
Zip code	277-8577
Address	6-5-1, Kashiwanoha, Kashiwa, 277-8577, Japan
TEL	04-7133-1111
Homepage URL
Email	yutsukad@east.ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital East
Institute
Department

Funding Source
Organization	National Cancer Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Institutional review board of National Cancer Center
Address	5-1-1, Tyuoku Tsukiji, Tokyo
Tel	03-3542-2511
Email	irst@ml.res.ncc.go.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	国立がん研究センター東病院（千葉県） 国立がん研究センター中央病院（東京都） 久留米大学（福岡県） 藤田保健衛生大学（愛知県） 防衛医科大学校（埼玉県） 帝京ちば総合医療センター（千葉県） 愛知県がんセンター中央病院（愛知県） 青森県立中央病院（青森県） 静岡県立静岡がんセンター（静岡県） 大阪府立成人病センター（大阪府） 高野病院（熊本県） 埼玉県立がんセンター（埼玉県） 東京女子医科大学（東京都）

Other administrative information
Date of disclosure of the study information	2012 Year 12 Month 20 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	No longer recruiting
Date of protocol fixation	2012 Year 11 Month 27 Day
Date of IRB	2012 Year 11 Month 27 Day
Anticipated trial start date	2013 Year 01 Month 04 Day
Last follow-up date	2018 Year 07 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 12 Month 10 Day
Last modified on	2019 Year 12 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011175