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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000011993
Receipt No. R000014016
Scientific Title Preoperative chemoradiotherapy with irinotecan and S-1 for locally advanced rectal cancer
Date of disclosure of the study information 2013/10/09
Last modified on 2021/09/10

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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
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of neoadjuvant chemoradiotherapy with S-1 and irinotecan in patients with locally advanced rectal cancer.
Basic objectives2 Others
Basic objectives -Others To evaluate the predictive value of CD133/COX2 expression and CD8+ lymphocyte aggregation in pretreatment biopsy specimens for tumor regression
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 S-1(80mg/m2/day1-5,8-12,22-26,29-33)
irinotecan(80mg/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 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Hase
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
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information
2013 Year 10 Month 09 Day

Related information
URL releasing protocol https://academic.oup.com/bjsopen/article/4/2/301/6061323
Publication of results Partially published

Result
URL related to results and publications https://academic.oup.com/bjsopen/article/4/2/301/6061323
Number of participants that the trial has enrolled 49
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 Main results already published
Date of protocol fixation
2011 Year 04 Month 01 Day
Date of IRB
2011 Year 04 Month 22 Day
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
2023 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 10 Month 08 Day
Last modified on
2021 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014016

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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