UMIN-CTR Clinical Trial

Public title

Phase II study of XELOX plus bevacizumab as second-line chemotherapy prior oral fluoropyrimidine, irinotecan plus bevacizmab for metastatic colorectal cancer

Acronym

CCOG 1203

Scientific Title

Phase II study of XELOX plus bevacizumab as second-line chemotherapy prior oral fluoropyrimidine, irinotecan plus bevacizmab for metastatic colorectal cancer

Scientific Title:Acronym

CCOG 1203

Region

Japan

Condition

Unresectable metastatic or recurrent colorectal cancer

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy of XELOX plus bevacizumab as second-line chemotherapy for unresectable metastatic or recurrent colorectal cancer patients who have failed prior oral fluoropyrimidine, irinotecan plus bevacizumab

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

ORR;Over response rate

Key secondary outcomes

Progression free survival, Duration of disease control, Time to treatment-failure, Overall survival, Safety

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

XELOX plus bevacizumab therapy
Bevacizumab 7.5mg/kg day1
Oxaliplatin 130mg/m2 day1
Capecitabin 2000mg/m2/day day1-15

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)Histopathologically confirmed colorectal cancer
(2)Unresectable advanced colorectal cancer patient who have failed prior oral fluoropyrimidine , irinotecan plus bevacizumab
(3)Age of 20 years or older
(4)ECOG performance status 0-1
(5)Measurable or evaluable disease (RECIST ver.1.1.)
(6)Alife expectancy greater than 3 months
(7)satisfactory oral feeding
(8)Adequate organ function
(9)Written informed concent

Key exclusion criteria

1)Uncontrolled infection.
2)Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated
3)Previous history of thoromboembolitic disease,or necessity for antithrombotic drug.
4)Severe lung disease.(Interstitial lung disease or pulmonary fibrosis.)
5)Severe liver disease.
6)Severe renal failure.
7)Previous history of severe drug-induced allergy
8)Intestinal bleeding, ileus, bowel obstruction or uncontrolled peptic ulcer.
9)History of gastrointestinal perforation within 1 year.
10)Uncontrolled severe complications(DM, hypertension, diarrhea, et al.)
11)History of active double cancer.
12)Massive pleural effusion or ascites that required drainage.
13)Brain metastasis
14)Patients with psycho-neurological disease,central nervous system damage,cerebrovascular disorder
15)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.
16)Patient with untreated traumatic bone fracture.
17)Diathesis of bleeding (history of hemoptysis,including cavitation and/or necrosis in lung metastasis confirmed by imaging),coagulopathy.
18) Systemic administration of antiplatelet drug
19)Administration of immunosuppressants associated with organ transplantation
20)Patient who have peripheral nerve disorder
21)Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers.
22)Previous history of severe side effects for fluoropyrimidine
23)Not appropriate for the study at the physician's assessment

Target sample size

25

Name of lead principal investigator

1st name
Middle name
Last name	Goro Nakayama

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Gastroenterology

Zip code

Address

65 Tsurumai-cho Showa-ku Nagoya-city Aichi Japan

TEL

(81)52-744-2253

Email

goro@med.nagoya-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Miyuki Aoki

Organization

Clinical Oncology Group(CCOG)

Division name

Data Center

Zip code

Address

65 Tsurumai-cho Showa-ku Nagoya-city Aichi Japan

TEL

(81)52-744-2253

Homepage URL

http://www.med.nagoya-u.ac.jp/surgery2/scientific/ccog/

Email

norifumi@med.nagoya-u.ac.jp

Institute

Chubu Clinical Oncology Group (CCOG)

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

2013

Year

08

Month

22

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

No longer recruiting

Date of protocol fixation

2012

Year

04

Month

01

Day

Date of IRB

Anticipated trial start date

2012

Year

04

Month

04

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

08

Month

22

Day

Last modified on

2016

Year

11

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013517