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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030226
Receipt No. R000034444
Scientific Title A Phase II/III Randomized multicenter Trial of Intersphincteric resection (ISR) with or without Preoperative Chemotherapy for very low-lying Rectal Cancer(UMIN9510) -Additional study: How to predict the chemotherapy response-
Date of disclosure of the study information 2017/12/03
Last modified on 2017/12/02

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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(UMIN9510) -Additional study: How to predict the chemotherapy response-
Acronym A Phase II/III Randomized multicenter Trial of Intersphincteric resection (ISR) with or without Preoperative Chemotherapy for very low-lying Rectal Cancer(UMIN9510) -Additional study: How to predict the chemotherapy response-
Scientific Title A Phase II/III Randomized multicenter Trial of Intersphincteric resection (ISR) with or without Preoperative Chemotherapy for very low-lying Rectal Cancer(UMIN9510) -Additional study: How to predict the chemotherapy response-
Scientific Title:Acronym A Phase II/III Randomized multicenter Trial of Intersphincteric resection (ISR) with or without Preoperative Chemotherapy for very low-lying Rectal Cancer(UMIN9510) -Additional study: How to predict the chemotherapy response-
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the predictive value of CD133/COX2 expression and CD8+ lymphocyte aggregation in pretreatment biopsy specimens for tumor regression by neoadjuvant chemotherapy with FOLFOX
Basic objectives2 Others
Basic objectives -Others To evaluate the predictive value of CD133/COX2 expression and CD8+ lymphocyte aggregation in pretreatment biopsy specimens for prognostic benefit by neoadjuvant chemotherapy with FOLFOX
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pathological Complete Response rate
Tumor regression grade
Key secondary outcomes Relapse free survival (RFS)
Overall survival (OS)
Rate of local recurrence

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
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
Middle name
Last name Hideki Ueno
Organization National Defense Medical College
Division name Surgery
Zip code
Address 3-2 Namiki Tokorozawa Saitama
TEL 04-2995-1511
Email shinto@ndmc.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiji Shinto
Organization National Defense Medical College
Division name Surgery
Zip code
Address 3-2 Namiki Tokorozawa Saitama
TEL 04-2995-1511
Homepage URL
Email shinto@ndmc.ac.jp

Sponsor
Institute National Defense Medical College
Institute
Department

Funding Source
Organization National Defense Medical College
National Cancer Center Hospital East
Organization
Division
Category of Funding Organization Other
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 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
2017 Year 12 Month 03 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 Open public recruiting
Date of protocol fixation
2013 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We previously reported that increased CD8+ tumor-infiltrating lymphocytes, low tumor expression of CD133, and that of cyclooxygenase-2 (COX-2) could be useful pathological predictive markers of favorable tumor response to chemoradiotherapy (CRT) for rectal cancer (Shinto et al. Dis Colon Rect 2011; Ann Surg Oncol 2014). In this study, we aimed to evaluate the predictive power of the number of these three markers with regard to tumor regression and prognostic benefit after FOLFOX.

Management information
Registered date
2017 Year 12 Month 02 Day
Last modified on
2017 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034444

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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