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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017674
Receipt No. 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

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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
Email 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
Email yasinoue@clin.medic.mie-u.ac.jp

Sponsor
Institute Department of Gastrointestinal and Pediatric Surgery, Division of Reparative Medicine, Institute of Life Sciences, Mie University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020488

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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