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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008452
Receipt No. R000009914
Scientific Title Phase 1 study of chemoradiation with bevacizumab as preoperative treatment in locally advanced rectal cancer.
Date of disclosure of the study information 2012/07/18
Last modified on 2018/08/16

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Basic information
Public title Phase 1 study of chemoradiation with bevacizumab as preoperative treatment in locally advanced rectal cancer.
Acronym Phase 1 study of chemoradiation with bevacizumab as preoperative treatment in locally advanced rectal cancer.
Scientific Title Phase 1 study of chemoradiation with bevacizumab as preoperative treatment in locally advanced rectal cancer.
Scientific Title:Acronym Phase 1 study of chemoradiation with bevacizumab as preoperative treatment in locally advanced rectal cancer.
Region
Japan

Condition
Condition Locally advanced rectal cancer
Classification by specialty
Gastrointestinal surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the DLT, MTD and RD of bevacizumab plus sLV5FU2 and preoperative radiotherapy for locally advanced rectal cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes MTD RD
Key secondary outcomes Determination of non-dose limitting toxicities, Resection rate

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 bevacizumab 5kg/m2,
5FU 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 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 or lactating and woman with childbearing potential who lacked effective contraception
3)Man who lacked effective contraception
4)Evidence of thronbosis and need anti-coagulability drugs
5)With uncontrolled renal failure
6)With uncontrolled hypertention
7)With uncontrolled heart disease
8)With severe plumonary disease(intestinal pneumotitis, pulmonary fibrosis)
9)With gastrointestinal bleeding,obstruction, perforation
10) With active inflammatory bowel disease
11)With active infection
12)With brain metastasis
13)Synchronous or metachronous malignancy
14) Patient who received surgery within 28 days at registration
15) Any other cases who are regard 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 Paediatric Surgery, Divison of Reparative Medicine, Institute of Life Sciences,
Zip code
Address 174-2 Edobashi, Tsu, Mie, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Mie University Graduate School of Medicine
Division name Department of Gastrointestinal and Pediatric Surgery
Zip code
Address
TEL
Homepage URL
Email yasinoue@clin.medic.mie-u.ac.jp

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

Funding Source
Organization Department of Gastrointestinal and Paediatric 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
2012 Year 07 Month 18 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
2009 Year 04 Month 22 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 23 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
2012 Year 07 Month 17 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=R000009914

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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