UMIN-CTR Clinical Trial

Public title

Randomized phase 2 study of mFOLFOX6 plus bevacizumab versus
modified OPTIMOX plus bevacizumab for metastatic colorectal cancer

Acronym

Randomized phase 2 study of mFOLFOX6 plus bevacizumab versus
modified OPTIMOX plus bevacizumab for metastatic colorectal cancer

Scientific Title

Randomized phase 2 study of mFOLFOX6 plus bevacizumab versus
modified OPTIMOX plus bevacizumab for metastatic colorectal cancer

Scientific Title:Acronym

Randomized phase 2 study of mFOLFOX6 plus bevacizumab versus
modified OPTIMOX plus bevacizumab for metastatic colorectal cancer

Region

Japan

Condition

colorectal cancer

Classification by specialty

Gastroenterology	Hematology and clinical oncology	Gastrointestinal surgery
Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate safety and efficacy of first-line mFOLFOX6 plus bevacizumab and modified OPTIMOX plus bevacizumab for patients with unresectable colorectal cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

disease control survival

Key secondary outcomes

Progression-free survival
Overall survival
The incidence of adverse events

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

After 8 cycles of mFOLFOX 6 plus bevacizumab, patients receive UFT/LV with bevacizumab (until 5 cycles are completed or disease progression). And then, patients receive modified FOLFOX6 plus bevacizumab until disease progression.

Interventions/Control_2

Patients receive mFOLFOX6 plus bevacizumab until disease progression.

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

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) unresectable or recurrent colorectal cancer histologically diagnosted adenocarcinoma of the colon or rectum.
2) Age more than 20years and less than 75 years.
3) No prior therapies for metastatic and/or recurrent disease. Prior adjuvant therapy is allowed if it is completed at least 6 months before registration.
4) ECOG performance status of 0 or 1 .
5) Required baseline laboratory parameters (within 7 days before registration):
WBC more than 4000 and WBC less than 12000/mm3
Neutrophils more than 2000/mm3
Plt more than 100,000/mm3
Hb more than 9.0g/dl
GOT less than 100 IU/l
GPT less than 100 IU/l
T-Bil less than 1.5mg/dl
Creatinine less than 1.5mg/dl
6) Signed informed consent of the patient for the registration.

Key exclusion criteria

1) contraindication to 5-FU, oxaliplatin, UFT, calcium folinate, or bevacizumab.
2) moderate/severe pleural effusion, ascites or pericardial effusion.
3) brain metastases.
4) history of active other malignancies.
5) neuropathy.
6) history of thoromboembolitic disease.
7) uncontrollable Diabetes Mellitus or hypertension
8) interstitial lung disease, pulmonary fibrosis or severe pulmonary emphysema.
9) intestinal bleeding, ileus, bowel obstruction or uncontrolled peptic ulcer.
10) clinically significant infectious disease (body temperature more than 38.0 degrees)
11) urinary protein (more than 1+)
12) uncontrolled watery diarrhea.
13) pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant.
14) Any other cases who are regarded as inadequate for study enrollment by the attending doctors.

Target sample size

80

Name of lead principal investigator

1st name
Middle name
Last name	Tadamichi Denda

Organization

Chiba Cancer Center

Division name

Gastroenterology

Zip code

Address

666-2, Nitona-cho, Chuo-ku, Chiba city, Chiba, Japan

TEL

043-264-5431

Email

tdenda@chiba-cc.jp

Name of contact person

1st name
Middle name
Last name	Tadamichi Denda

Organization

Chiba Cancer Center Hospital

Division name

Gastroenterology

Zip code

Address

666-2, Nitona-cho, Chuo-ku, Chiba city, Chiba, Japan

TEL

043-264-5431

Homepage URL

Email

tdenda@chiba-cc.jp

Institute

Chiba Cancer Center 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

2010

Year

04

Month

12

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

Completed

Date of protocol fixation

2008

Year

06

Month

24

Day

Date of IRB

Anticipated trial start date

2008

Year

07

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

04

Month

12

Day

Last modified on

2017

Year

04

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004207