UMIN-CTR Clinical Trial

Public title

Phase II study of chemotherapy with Capecitabine/Bevacizumab in elderly patients with advanced and recurrent colorectal cancer

Acronym

Phase II study of chemotherapy with Capecitabine/Bevacizumab in elderly patients with advanced and recurrent colorectal cancer

Scientific Title

Phase II study of chemotherapy with Capecitabine/Bevacizumab in elderly patients with advanced and recurrent colorectal cancer

Scientific Title:Acronym

Phase II study of chemotherapy with Capecitabine/Bevacizumab in elderly patients with advanced and recurrent colorectal cancer

Region

Japan

Condition

advanced and/or recurrent colorectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the clinical efficacy and safety of Capecitabine plus bevacizumab in elderly patients with advanced and recurrent 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,Response rate,Disease Contorol Rate,Safty

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

Capecitabine plus bevacizumab therapy
Capecitabine:2,000mg/m2 twice daily (orally, day1 after dinner:day8 after breakfast)
Bevacizumab:7.5mg/kg day 1
The treatment is repeated every three 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

70

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1)histologically confirmed colorectal cancer
(2)Advanced or recurrent colorectal cancer that is first line chemotherapy
(3)Age of 70 years or older
(4)Measurable or evaluable disease (RECIST ver.1.1.)
(5)ECOG performance status of 0-2
(6)Life expectancy more than 3 months
(7)Adequate organ functions
Neutrophil: => 1500/mm3
Platelet: => 100,000/mm3
Hemoglobin concentration: => 9.0g/dl
Total bilirubin: <= 1.5mg/dl
AST or ALT: <= 100IU/I
Cr: <= 1.2mg/dl
proteinuria: <= 1+
(8) Written informed consent after the explanation of the content of the examination

Key exclusion criteria

(1)active brain metastases
(2) Complication of cerebrovascular disease or symptoms within 1 year
(3) Patient receiving surgical procedure or such as skin-open biopsy, trauma surgery, or other more intensive surgeries within 4 weeks or aspiration biopsy within a week
(4) History of gastrointestinal perforation within 1 year.
(5) Uncontrollable peptic ulcer, Hypertension, diarrhea, infections
(6) A bleeding tendency, coagulation disorder or abnormal coagulation factor
(7) bleeding diathesis or receiving anticoagulant drug(except Aspirin under 325mg/day)
(8) Serious heart disease
(9) History of active double cancer within 5 years
(10)History of the serious hypersensitivity for capecitabine or bevacizumab
(11)Other conditions not suitable for this study

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Kimikazu Hamano

Organization

Yamafuchi University

Division name

Medical Bioregulation Department of Organ Regulatory Surgery

Zip code

Address

1-1-1 Minamikogushi , Ube, 755-8505, Japan

TEL

0836-22-2260

Email

Name of contact person

1st name
Middle name
Last name	Tadahiko Enoki

Organization

Yamafuchi University

Division name

Medical Bioregulation Department of Organ Regulatory Surgery

Zip code

Address

1-1-1 Minamikogushi , Ube, 755-8505, Japan

TEL

Homepage URL

Email

Institute

Yamafuchi University
Medical Bioregulation Department of Organ Regulatory Surgery

Institute

Department

Personal name

Organization

Yamafuchi University
Medical Bioregulation Department of Organ Regulatory Surgery

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

2013

Year

03

Month

11

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

Open public recruiting

Date of protocol fixation

2012

Year

09

Month

07

Day

Date of IRB

Anticipated trial start date

2012

Year

09

Month

07

Day

Last follow-up date

2017

Year

08

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

09

Day

Last modified on

2013

Year

03

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011947