Unique ID issued by UMIN | UMIN000008452 |
---|---|
Receipt number | 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 19:00:30 |
Phase 1 study of chemoradiation with bevacizumab as preoperative treatment in locally advanced rectal cancer.
Phase 1 study of chemoradiation with bevacizumab as preoperative treatment in locally advanced rectal cancer.
Phase 1 study of chemoradiation with bevacizumab as preoperative treatment in locally advanced rectal cancer.
Phase 1 study of chemoradiation with bevacizumab as preoperative treatment in locally advanced rectal cancer.
Japan |
Locally advanced rectal cancer
Gastrointestinal surgery | Radiology |
Malignancy
NO
To determine the DLT, MTD and RD of bevacizumab plus sLV5FU2 and preoperative radiotherapy for locally advanced rectal cancer.
Safety
Exploratory
Pragmatic
Phase I
MTD RD
Determination of non-dose limitting toxicities, Resection rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
bevacizumab 5kg/m2,
5FU dose level 1-3
20 | years-old | <= |
80 | years-old | > |
Male and Female
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
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
12
1st name | |
Middle name | |
Last name | Yasuhiro Inoue |
Mie University Graduate School of Medicine
Department of Gastrointestinal and Paediatric Surgery, Divison of Reparative Medicine, Institute of Life Sciences,
174-2 Edobashi, Tsu, Mie, Japan
1st name | |
Middle name | |
Last name |
Mie University Graduate School of Medicine
Department of Gastrointestinal and Pediatric Surgery
yasinoue@clin.medic.mie-u.ac.jp
Department of Gastrointestinal and Paediatric Surgery
Division of Reparative Medicine
Institute of Life Sciences
Mie University Graduate School of Medicine
Department of Gastrointestinal and Paediatric Surgery
Division of Reparative Medicine
Institute of Life Sciences
Mie University Graduate School of Medicine
Self funding
NO
2012 | Year | 07 | Month | 18 | Day |
Unpublished
Completed
2009 | Year | 04 | Month | 22 | Day |
2009 | Year | 04 | Month | 23 | Day |
2012 | Year | 07 | Month | 17 | Day |
2018 | Year | 08 | Month | 16 | Day |
Value
https://center6.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 |