UMIN-CTR Clinical Trial

Public title

Phase II study of XELIRI and High-dose bevacizumab as second-line therapy in patients with metastatic colorectal cancer

Acronym

AVIRIX study

Scientific Title

Phase II study of XELIRI and High-dose bevacizumab as second-line therapy in patients with metastatic colorectal cancer

Scientific Title:Acronym

AVIRIX study

Region

Japan

Condition

colorectal cancer

Classification by specialty

Gastroenterology

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the effectiveness and safety of High-dose bevacizumab and irinotecan as second-line therapy in patients with metastatic colorectal cancer previously treated with oxaliplatin, and bevacizumab

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Progression Free Survival

Key secondary outcomes

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
Bevacizumab 10mg/kg day1
Irinotecan 150mg/m2 day1
Capecitabin 2,000mg/m2/day day1-8

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.Histological confirmation of colorectal cancer
2.Unrecectable metastatic colorectal cancer
3.Metastatic colorectal cancer which has prior therapy of Oxliplatin-based chemotherapy with bevacizumab
4.Age over 20
5.Group(ECOG) Performance Status (PS) 0-1
6.An evaluable lesion is confirmed with objective documents such as CT,MRI within 4 weeks before registration
7.Satisfactory oral feeding
8. Have the treatment-free interval of 2-4 weeks since previous completion of treatment by a registration day
9.Vital organ functions are preserved within 2 weeks prior to entry
10.Life expectancy of more than 3 months
11. Written consent is taken

Key exclusion criteria

1.History of severe allergy
2.Pregnant or lactating women or women of childbearing potential
3.Severe infection disease
4.HBsAg(+) or HBV-DNA(+)
5.Previous history of hemoptysis or evidence of bleeding diathesis or coagulopathy
6. Metastases to the CNS
7. Complication of inflammation or active gastrointestinal
8. Non-healing wound
9. anti-platelets therapy
10. History of thrombosis or cerebrovascular disorder
11. Uncontrolled high blood pressure
12. Serious heart disease
13. Uncontrolled diarrhea
14.Paresis of intestine or intestinal obstruction
15.Interstitial pneumonitis
16.Serious peritoneal fluid and pericardial fluid
17.Multiple primary cancer which heals within five years

18. receiving atazanavir sulfate
19. requiring steroid drug
20.Have the homo and double heterozygote of *6,*28.
21. Other conditions not suitable for this study

Target sample size

38

Name of lead principal investigator

1st name
Middle name
Last name	Sotarou akatsuka

Organization

Yokohama Rosai Hospital

Division name

Division of Medical Oncology

Zip code

Address

3211 Kozukue-Cho;kohoku-Ku, Yokohama City, Kanagawa Prefecture, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Yokohama Rosai Hospital

Division name

Division of Medical Oncology

Zip code

Address

3211 Kozukue-Cho;kohoku-Ku, Yokohama City, Kanagawa Prefecture, Japan

TEL

045-474-8111(5147)

Homepage URL

Email

sakatsuk@yokohamah.rofuku.go.jp

Institute

Yokohama Rosai Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

2012

Year

07

Month

14

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

Preinitiation

Date of protocol fixation

2012

Year

06

Month

30

Day

Date of IRB

Anticipated trial start date

2012

Year

07

Month

14

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

07

Month

13

Day

Last modified on

2012

Year

07

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009910