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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011115
Receipt No. R000012597
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 2013/07/13
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-2 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-2 TRIAL)
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the safety and efficacy of neoadjuvant chemoradiation therapy with TS-1 and CPT-11 in patients with locally advanced resectable rectal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pathological Complete Response rate
Key secondary outcomes Relapse free survival (RFS)
Overall survival (OS)
Rate of local recurrence
Completion rate of neoadjuvant chemoradiation therapy
R0 resection rate
Down-staging rate
Safety
Relation between a nutrition index, and adverse event, perioperative complications and prognosis

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 Maneuver
Interventions/Control_1 S-1(80-120mg/body/day1-5,8-12,22-26,29-33)
CPT-11(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.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 (longest diameter is less than 10 mm)
(v) Not type 4(Diffuse Infiltrative Type)
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. Oral intake possible
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 administration of corticosteroids
13. Patients of hepatitis B virus suface antigen positivity
14.Contraindication of S-1or CPT-11
15. Patients judged inappropriate for this study by the physicians
Target sample size 40

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
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
2013 Year 07 Month 13 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2013 Year 07 Month 02 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 01 Day
Last follow-up date
2018 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
2018 Year 09 Month 30 Day
Date analysis concluded
2019 Year 02 Month 28 Day

Other
Other related information additional study
[A prediction of treatment effect Of preoperative Chemoradiotherapy for locally advanced rectal cancer with using DNA microarray]
Anticipated trial start date
2014/12/5

Suspension
2016/11/17

Management information
Registered date
2013 Year 07 Month 04 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=R000012597

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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