UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009510 |
|---|---|
| Receipt number | R000011175 |
| Scientific Title | A Phase II/III Randomized multicenter Trial of Intersphincteric resection (ISR) with or without Preoperative Chemotherapy for very low-lying Rectal Cancer |
| Date of disclosure of the study information | 2012/12/20 |
| Last modified on | 2019/12/28 15:24:49 |
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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
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
yutsukad@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011175
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