UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase 1 study of chemoradiation with bevacizumab as preoperative treatment in locally advanced rectal cancer.
Title of the study (Brief title)	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	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,
Address	174-2 Edobashi, Tsu, Mie, Japan
TEL
Email

Public contact
Name of contact person
Organization	Mie University Graduate School of Medicine
Division name	Department of Gastrointestinal and Pediatric Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 04 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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