UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013598 |
|---|---|
| Receipt number | R000015887 |
| Scientific Title | Phase2 trial of neoadjuvant chemotherapy with S-1 plus radiation in patients with locally advanced rectal cancer |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2019/11/06 20:35:23 |
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Basic information
Public title
Phase2 trial of neoadjuvant chemotherapy with S-1 plus radiation in patients with locally advanced rectal cancer
Acronym
Phase2 trial of neoadjuvant
chemotherapy with S-1 plus radiation in patients with locally advanced rectal cancer
Scientific Title
Phase2 trial of neoadjuvant chemotherapy with S-1 plus radiation in patients with locally advanced rectal cancer
Scientific Title:Acronym
Phase2 trial of neoadjuvant
chemotherapy with S-1 plus radiation in patients with locally advanced rectal cancer
Region
| Japan |
Condition
Condition
Low rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to establish the feasibility and efficacy of preoperative radiation with TS-1 in patients with locally advance rectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Rate of pathological complete response
Key secondary outcomes
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
TS-1:80mg/m2-120mg/m2
day1-5,8-12,15-19,22-26,29-33
Radiation:1.8Gy of consecutive 5days,
Total dose 45 Gy
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 low Rectum adenocarcinoma(without Rs)
2.Preoperative CT or MRI findings
the clinical stage is T3-4 and any N
3.Recectable
4.No evidence of peritoneal
metastasis, liver metastasis and
distant metastasis.
5.age:20-80years old
6.Performance status 0-1
7.Without prior anti-tumor therapy
8. Adequate organ function
9.the case can eat
10.Written IC
Key exclusion criteria
1.Impossible to receive TS-1 contained chemotherapy
2.Recieving the radiation therapy in a pelvis
3.Infection
4.Serious complications
5.Myocardial infarction within the last 6 months, previous serious medical illness or allergy for drug
6.Multiple malignancies
7. Pleural effusion or ascites requiring
8.Current or previous Brain
metastasis
9.Diarrhea(watery stool)
10.Fresh bleeding of digestive organs
11.Need to treatment with flucytosine, atazanavir sulfate, or warfalin
12.Evidence of psychiatric disability interfering with enrollment to clinical trial
13.Pregnant or lactating women,
women who are capable of pregnancy or intend to get pregnant
14.Man of wanting child
15.Need Systemically administration of corticosteroids
16.Patients judged inappropriate for this study by the physicians
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kimihiko |
| Middle name | |
| Last name | Funahashi |
Organization
Toho University School of Medicine
Division name
Division of general and gastroenterological surgery, Department of Surgery (Omori)
Zip code
143-8541
Address
6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541. Japan
TEL
03-3762-4151
kingkong@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Kimihiko |
| Middle name | |
| Last name | Funahashi |
Organization
Division of general and gastroenterological surgery, Department of Surgery (Omori)
Division name
Division of general and gastroenterological surgery, Department of Surgery (Omori)
Zip code
143-8541
Address
6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541. Japan
TEL
03-3762-4151
Homepage URL
kingkong@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Toho University
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
Toho University Omori Medical Center
Address
6-11-1 Omorinishi Ota-ku Tokyo, Japan
Tel
03-3762-4151
kingkong@med.toho-u.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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | 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
Completed
Date of protocol fixation
| 2012 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2013 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 01 | Day |
Last modified on
| 2019 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015887
