UMIN-CTR Clinical Trial

Public title

A Phase II Study of Bi-weekly XELOX with Bevacizumab for patient with Metastatic Colorectal Cancer as first-line chemotherapy

Acronym

Bi-weekly XELOX with Bevacizumab

Scientific Title

A Phase II Study of Bi-weekly XELOX with Bevacizumab for patient with Metastatic Colorectal Cancer as first-line chemotherapy

Scientific Title:Acronym

Bi-weekly XELOX with Bevacizumab

Region

Japan

Condition

advanced and/or recurrent colorectal cancer

Classification by specialty

Medicine in general	Gastroenterology	Surgery in general

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To evaluate the efficacy and safety of bi-weekly XELIRI plus bevacizumab in advanced colorectal cancer as first-line chemotherapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

progression free survival

Key secondary outcomes

overall survival
Time to Treatment Failur
Response Rate
Disease Control Rate
Relative Dose Intensity
Rate of Adverse Event
safety

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

XELIRI plus bevacizumab therapy
/Capecitabine;2,000 mg/m2 day1-8(orally, day1 after dinner; day8 after breakfast)
/Oxaliplatin 85 mg/m2 day1
/Bevacizumab: 5mg/kg day 1
The treatment is repeated every two weeks until disease progression or severe toxicity

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Written informed consent after the explanation of the content of the examination
(2) Age of 20 years or older
(3) ECOG PS 0-1
(4) Life expectancy more than 3 months
(5) Histopathologically confirmed colorectal cancer
(6) Measurable or evaluable disease (RECIST ver.1.1)
(7) Metastatic colorectal cancer which has non prior therapy
(8)Adequate organ functions

Key exclusion criteria

(1) Severe renal function disorder
(2) History of serious drug hypersensitivity or a history of drug allergy
(3) History of active double cancer within 5 years
(4) Active infections
(5) Distinctly abnormal ECG or cardiovascular disease
(6) Cpmplication of thromboembolism,severe pulmonary disease(interstitial pneumonia, pulmonary fibrosis, mild Emphysema)
"(7) complication of GI perforation or hemorrhage ,Paresis of intestine or intestinal obstruction

"
(8) Massive pleural effusion or ascites that required drainage
(9) Brain metastasis
(10) Complication of mental disorder,CNS disease, cerebrovascular disease.
(11) Uncontrollable hypertension or diabetes mellitus
(12) Uncontrollable diarrhea
"(13) Patients with non-healing wounds,or surgery (thoracotomy, laparotomy) within 4 weeks
"
(14) Non-healing fracture
(15) Bleeding diathesis or receiving anticoagulant drug(except Aspirin under 325mg/day)
(16) Pregnant or lactating woman
(17) Peripheral neuropathy
(18) Other conditions not suitable for this study

Target sample size

45

Name of lead principal investigator

1st name	Shoichi
Middle name
Last name	Hazama

Organization

Yamaguchi University Graduate School of Medicibe

Division name

Digestive surgery and surgical oncology

Zip code

755-8505

Address

1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan

TEL

+81-836-22-2264

Email

hazama@yamaguchi-u.ac.jp

Name of contact person

1st name	Shoichi
Middle name
Last name	Hazama

Organization

Yamaguchi University Graduate School of Medicibe

Division name

Digestive surgery and surgical oncology

Zip code

755-8505

Address

1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan

TEL

+81-836-22-2264

Homepage URL

Email

hazama@yamaguchi-u.ac.jp

Institute

Yamaguchi University Graduate School of Medicibe, Digestive surgery and surgical oncology

Institute

Department

Personal name

Organization

Yamaguchi University Graduate School of Medicibe, Digestive surgery and surgical oncology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Yamaguchi University

Address

1-1-1 Minami-Kogushi

Tel

0836222428

Email

me223@yamaguchi-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

03

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Terminated

Date of protocol fixation

2013

Year

03

Month

17

Day

Date of IRB

2012

Year

12

Month

25

Day

Anticipated trial start date

2013

Year

03

Month

18

Day

Last follow-up date

2022

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

03

Month

17

Day

Last modified on

2022

Year

03

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012008