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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026306
Receipt No. R000030028
Scientific Title Preoperative chemoradiotherapy with irinotecan and S-1 for locally advanced rectal cancer
Date of disclosure of the study information 2017/02/28
Last modified on 2019/09/11

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Basic information
Public title Preoperative chemoradiotherapy with irinotecan and S-1 for locally advanced rectal cancer
Acronym Preoperative chemoradiotherapy with irinotecan and S-1 for locally advanced rectal cancer
Scientific Title Preoperative chemoradiotherapy with irinotecan and S-1 for locally advanced rectal cancer
Scientific Title:Acronym Preoperative chemoradiotherapy with irinotecan and S-1 for locally advanced rectal cancer
Region
Japan

Condition
Condition Locally advanced rectal cancer
Locally advanced anal cancer
Classification by specialty
Hematology and clinical oncology Gastrointestinal surgery Radiology
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 chemoradiotherapy with S-1 and irinotecan
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pathological Complete Response rate
Predictive value for tumor regression
Key secondary outcomes Relapse free survival (RFS)
Overall survival (OS)
Rate of local recurrence
Safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 We select patients by CD133/COX2 expression and CD8+ lymphocyte aggregation in pretreatment biopsy specimens, and treat them with preoperative CRT listed below.
S-1(80mg/m2/day1-5,8-12,22-26,29-33)
irinotecan(60mg/m2/day1,8,22,29)
Radiotherapy(1.8Gy/ 5 times a week for 5 weeks,45Gy/total)
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
80 years-old >=
Gender Male and Female
Key inclusion criteria (1) Rectal or anal cancer whose lower tumor margin is below the peritoneal reflection. The clinical stage is II or III.
(2) Histologically confirmed adenocarcinoma
(3) Without prior anti-tumor therapy
(4) Age:20-80years old
(5) Performance status 0-2
(6) Adequate organ function
WBC>= 4,000 <= 15,000/mm3
neutro>= 2,000/mm3
Plt>= 100,000/mm3
Hb>= 8.0g/dl
Cr<= 1.5mg/dl
T-Bil<= 1.5mg/dl
AST, ALT<= double of the upper limit
(7) Written IC with date
Key exclusion criteria Patients judged inappropriate for this study by the physicians
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Hideki
Middle name
Last name Ueno
Organization National Defense Medical College
Division name Surgery
Zip code 359-8513
Address 3-2 Namiki Tokorozawa Saitama
TEL 04-2995-1511
Email shinto@ndmc.ac.jp

Public contact
Name of contact person
1st name Eiji
Middle name
Last name Shinto
Organization National Defense Medical College
Division name Surgery
Zip code 359-8513
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
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Self-Defense Forces Central Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Clinical Research Review Board of Saitama Medical Universi ty
Address 38, Morohongo, Moroyama, Iruma-gun, Saitama-Pref, Japan , Saitama
Tel 049-276 -1662
Email tokutei@saitama-med.ac.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 防衛医科大学校(埼玉県)、自衛隊中央病院(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 28 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 Enrolling by invitation
Date of protocol fixation
2017 Year 02 Month 06 Day
Date of IRB
2019 Year 05 Month 28 Day
Anticipated trial start date
2017 Year 02 Month 06 Day
Last follow-up date
2029 Year 01 Month 31 Day
Date of closure to data entry
2029 Year 01 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 02 Month 25 Day
Last modified on
2019 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030028

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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