UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017674 |
|---|---|
| Receipt number | R000020488 |
| Scientific Title | Phase I study of irinotecan, S-1 and oxaliplatin in combination with radiation therapy in patients with advanced rectal cancer |
| Date of disclosure of the study information | 2015/05/27 |
| Last modified on | 2018/08/16 18:59:39 |
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Basic information
Public title
Phase I study of irinotecan, S-1 and oxaliplatin in combination with radiation therapy in patients with advanced rectal cancer
Acronym
Phase I study of irinotecan, S-1 and oxaliplatin in combination with radiation therapy in patients with advanced rectal cancer
Scientific Title
Phase I study of irinotecan, S-1 and oxaliplatin in combination with radiation therapy in patients with advanced rectal cancer
Scientific Title:Acronym
Phase I study of irinotecan, S-1 and oxaliplatin in combination with radiation therapy in patients with advanced rectal cancer
Region
| Japan |
Condition
Condition
advanced rectal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the DLT, MTD and RD of oxaliplatin in combination regimen of irinotecan/S-1/oxaliplatin and preoperative radiotherapy for advanced rectal cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MTD,DLT,RD
Key secondary outcomes
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 80mg/m2, irinotecan 40mg/m2,
oxaliplatin dose level 1-3
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 rectal adenocarcinoma
2)T3 or T4 or N1-3 disease
3)ECOG PS 0-1
4)Expectation of over 3 months survival
5)Patients with adequate main organ function
6)Patient with written informed consent
Key exclusion criteria
1)Previous history of drug-induced allergy
2)Pregnant of lactating and woman with childbearing potential who lacked effective contaception
3)Man who lacked effective contraception
4)With uncontrolled renal failure
5)With uncontrolled heart disease
6)With severe plumonary disease
7)With gastrointestinal bleeding, obstruction, perforation
8)With active inflammatory bowel disease
9)With active infection
10)With large amount of ascites, pleural effusion, or pericardial effusion
11)Any other cases who are regarded as inadequate for study enrollment by the investigator
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Inoue |
Organization
Mie University Graduate School of Medicine
Division name
Department of Gastrointestinal and Pediatric Surgery, Division of Reparative Medicine, Institute of Life Sciences
Zip code
Address
2-174 Edobashi, Tsu, Mie, 514-8507, Japan
TEL
059-232-1111
yasinoue@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Inoue |
Organization
Mie University Graduate School of Medicine
Division name
Department of Gastrointestinal and Pediatric Surgery
Zip code
Address
2-174 Edobashi, Tsu, Mie, 514-8507, Japan
TEL
059-232-1111
Homepage URL
yasinoue@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Department of Gastrointestinal and Pediatric Surgery, Division of Reparative Medicine, Institute of Life Sciences, Mie University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastrointestinal and Pediatric Surgery, Division of Reparative Medicine, Institute of Life Sciences, Mie University Graduate School of Medicine
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 27 | 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
| 2015 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 27 | 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 | 25 | Day |
Last modified on
| 2018 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020488
