UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011115 |
|---|---|
| Receipt number | 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 17:00:40 |
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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
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
samrai@tcog.jp
Sponsor or person
Institute
The Tokyo Cooperative Oncology Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012597
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