UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017720 |
|---|---|
| Receipt number | R000020527 |
| Scientific Title | Clinical stusy of induction S-1+Oxaliplatin+/-Cetuximab chemotherapy followed by short-course chemoradiotherapy in locally advanced ugly rectal cancer |
| Date of disclosure of the study information | 2015/06/01 |
| Last modified on | 2015/05/28 14:05:13 |
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Basic information
Public title
Clinical stusy of induction S-1+Oxaliplatin+/-Cetuximab chemotherapy followed by short-course chemoradiotherapy in locally advanced ugly rectal cancer
Acronym
Clinical stusy of induction S-1+Oxaliplatin+/-Cetuximab chemotherapy followed by short-course chemoradiotherapy in locally advanced ugly rectal cancer
Scientific Title
Clinical stusy of induction S-1+Oxaliplatin+/-Cetuximab chemotherapy followed by short-course chemoradiotherapy in locally advanced ugly rectal cancer
Scientific Title:Acronym
Clinical stusy of induction S-1+Oxaliplatin+/-Cetuximab chemotherapy followed by short-course chemoradiotherapy in locally advanced ugly rectal cancer
Region
| Japan |
Condition
Condition
locally advanced rectal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
safety and efficiency of induction chemotherapy(TS-1/L-OHP+/- Cetuximab) followed by chemoradiotherapy and surgery in locally advanced rectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
pathologival complete response rate
Key secondary outcomes
Adverse event
Compliance to induction chemotherapy
R0 resection rate
Down-staging rate(T,N stage)
Tumor regression grade
LFS; local recurrence free survival
RFS; Recurrence free survival
OS; Overall survival
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/Oxaliplatin; treatment dose was decided by body mass index
Cetuximab was used only Kras wild type
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) T3 lower rectal cancer with mesorectal fascia involvement
2) T4a or T4b tumors
3) lateral lymph node swelling with the cut-off size larger 5mm measured on axial view at shorter axis.
Key exclusion criteria
inflammatory bowel disease
cardiac disease
medical conditions that would not permit the patient to complete the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidenori Yanagi |
Organization
Meiwa Hospital
Division name
Surgery
Zip code
Address
4-31 Agenaruo-cho, Nishinomiya, Hyogo
TEL
+81-798-47-1767
n_beppu@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naohito Beppu |
Organization
Meiwa Hospital
Division name
Surgery
Zip code
Address
4-31 Agenaruo-cho, Nishinomiya, Hyogo
TEL
+81-798-47-1767
Homepage URL
n_beppu@yahoo.co.jp
Sponsor or person
Institute
Meiwa Hospital department of surgery
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
明和病院(兵庫県)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 28 | Day |
Last modified on
| 2015 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020527
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
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