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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001639
Receipt No. R000001970
Scientific Title S-1 combined preoperative neoadjuvant Multimodality therapy with Radiation and Irinotecan for locally advanced rectal cancer
Date of disclosure of the study information 2009/01/15
Last modified on 2019/01/07

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Basic information
Public title S-1 combined preoperative neoadjuvant Multimodality therapy with Radiation and Irinotecan for locally advanced rectal cancer
Acronym S-1 combined preoperative neoadjuvant Multimodality therapy with Radiation and Irinotecan for locally advanced rectal cancer
(SAMRAI-1 TRIAL)
Scientific Title S-1 combined preoperative neoadjuvant Multimodality therapy with Radiation and Irinotecan for locally advanced rectal cancer
Scientific Title:Acronym S-1 combined preoperative neoadjuvant Multimodality therapy with Radiation and Irinotecan for locally advanced rectal cancer
(SAMRAI-1 TRIAL)
Region
Japan

Condition
Condition locally advanced resectable rectal cancer
Classification by specialty
Gastrointestinal surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To estimate the maximum tolerated dose (MTD) and the recommended dose (RD) of neoadjuvant chemoradiation therapy with TS-1 and CPT-11 in patients with locally advanced resectable rectal cancer
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Maximum tolerated dose
Recommended dose
Key secondary outcomes Safety
R0 resection rate
Down-staging rate
pathological Complete Response rate

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 TS-1:day1-5,8-12, 22-26,29-33
CPT-11:day1,8,22,29
Radiotherapy: 5 times a week for 5 weeks
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.Histologically confirmed Rectum adenocarcinoma
2. Preoperative findings
i.The clinical stage is T3-4 and N0-2
ii.Main lesion of the tumor is located at the Ra or Rb
iii.Lower tumor margin is below the peritoneal reflection
iv.No extra mesorectal lymph node swelling (Shorter diameter is less than 10 mm)
3. No evidence of peritoneal metastasis, liver metastasis and distant metastasis
4. age:20-80years old
5. Without prior anti-tumor therapy
6. Adequate organ function
7. Normal ECG
8. Performance status 0-1
9. the case can eat
10.Written IC
Key exclusion criteria 1.Previous history of severe drug-induced allergy
2.Multiple malignancies to be treated or synchronous colorectal cancer
3.Need to treatment with flucytosine or atazanavir sulfate
4. Patient with homozygous genotype of UGT1A1*28/*28 or UGT1A1*6/*6, with combined heterozygous genotypes of UGT1A1*28 and UGT1A1*6
5. Active infections
6. Serious complications
7.Previous history of Interstitial Pneumonitis
8.Pleural effusion or ascites requiring treatment.
9. Active digestive tract bleeding
10. Severe watery diarrhea
11. Pregnant or nursing
12.Systemic administartion of corticosteroids
13. Patients of hepatitis B virus suface antigen positivity
14. Patients judged inappropriate for this study by the physicians
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiko Watanabe
Organization Kitasato University School of Medicine
Division name Department of Surgery
Zip code
Address 1-15-1 Kitasato Minami-ku Sagamihara-City Kanagawa
TEL 042-778-8111
Email samrai@tcog.jp

Public contact
Name of contact person
1st name
Middle name
Last name SAMRAI affairs office
Organization The Tokyo Cooperative Oncology Group
Division name Clinical Study Promotion Agency
Zip code
Address Toa-Bldg.4F, 2-1-18 Hamamatsu-cho Minato-ku Tokyo Japan
TEL 03-5401-5020
Homepage URL
Email samrai@tcog.jp

Sponsor
Institute The Tokyo Cooperative Oncology Group
Institute
Department

Funding Source
Organization TAIHO PHARMACEUTICAL CO.,LTD
Organization
Division
Category of Funding Organization Profit 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
2009 Year 01 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.thegreenjournal.com/article/S0167-8140(16)31148-3/abstract
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 Completed
Date of protocol fixation
2008 Year 12 Month 12 Day
Date of IRB
Anticipated trial start date
2009 Year 02 Month 01 Day
Last follow-up date
2015 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 01 Month 15 Day
Last modified on
2019 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001970

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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