UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026306 |
|---|---|
| Receipt number | 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 | 2022/03/03 08:47:04 |
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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
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
shinto@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
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
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
No longer recruiting
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
| 2022 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030028
