UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011552
Receipt number R000013517
Scientific Title Phase II study of XELOX plus bevacizumab as second-line chemotherapy prior oral fluoropyrimidine, irinotecan plus bevacizmab for metastatic colorectal cancer
Date of disclosure of the study information 2013/08/22
Last modified on 2016/11/16 09:05:53

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Basic information

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

Condition

Unresectable metastatic or recurrent colorectal cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

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


Assessment

Primary outcomes

ORR;Over response rate

Key secondary outcomes

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


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

Chubu Clinical Oncology Group (CCOG)

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2013 Year 08 Month 22 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name