UMIN-CTR Clinical Trial

Public title

Phase II study of Bevacizumab plus modified OPTIMOX1 in patients with unresectable advanced/recurrent colorectal cancer

Acronym

Phase II study of Bevacizumab plus modified OPTIMOX1 in patients with unresectable advanced/recurrent colorectal cancer
(TCOG GI-0802)

Scientific Title

Phase II study of Bevacizumab plus modified OPTIMOX1 in patients with unresectable advanced/recurrent colorectal cancer

Scientific Title:Acronym

Phase II study of Bevacizumab plus modified OPTIMOX1 in patients with unresectable advanced/recurrent colorectal cancer
(TCOG GI-0802)

Region

Japan

Condition

Unresectable advanced/recurrent colorectal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate safety and efficacy of bevacizumab plus modified OPTIMOX1 therapy for unresectable advanced/recurrent colorectal cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Duration of disease control

Key secondary outcomes

Safety
Reintroduction rate
Overall response rate
Overall survival

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

1-6 Course
Bevacizumab+mFOLFOX6
7-18 Course
Bevacizumab+sLV5FU2
19- Course
Bevacizumab+mFOLFOX6

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

74

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. Written IC
2. Age 20 to 74
3. Performance status 0-1(ECOG)
4. Life expectancy estimated>=3 months
5. Histologically confirmed Colorectal Cancer
6. With at least one measurable lesion
7. Sufficient organ functions

Key exclusion criteria

1. Pleural effusion,peritoneal fluid,and pericardial fluid
2. Symptomatic brain metastasis
3. Active concomitant malignancy
4.With Neurological disorder of brain blood vessel
5. Any surgical treatmentsincluding skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks (except for a CV-port procedure one week or more earlier)or aspiration biopsy within one week
6. Administering antithrombotic drug to the thrombus syndrome within seven days
7. Anti-platelets therapy(including aspirin and NSAIDS)
8. Bleeding tendency,coagulation abnormality
9. Fresh hemorrhage from digestive tube,intestines tube paralysis,intestinal obstruction and uncontrolled peptic ulcer
10 current or previous (within one year) history of GI perforation
11. Traumatic fracture of unrecovery
12. Renal damage that requires treatment
13. High blood pressure and diabetic that cannot be controlled
14. Symptomatic or asymptomatic but treated heart disease
15. With a history of allergic response to Fluorouracil or Levofolinate calcium or Platinium
16. Interstitial pneumonitis, pulmonary fibrosis
17. Peripheral neuropathy of grade 1(CTCAE v.3.0) or more
18. Infectious disease that cannot be controlled
19. Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers.
20. Man who doesn't have intention to which it practices birth control
21. Other conditions not suitable for this study

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Atsushi Sato

Organization

Hirosaki University Graduate School of Medicine

Division name

Department of Medical Oncology

Zip code

Address

5 Zaifu-cho Hirosaki-city Aomori Japan

TEL

0172-39-5346

Email

gi-0802@tcog.jp

Name of contact person

1st name
Middle name
Last name	TCOG Gastric Cancer affairs office

Organization

The Tokyo Cooperative Oncology Group

Division name

Clinical Study Promotion Agency

Zip code

Address

Toa-Bldg. 4F 2-1-18 Hamamatsu-cho Minato-ku Tokyo Japan

TEL

03-5401-5020

Homepage URL

Email

gi-0802@tcog.jp

Institute

The Tokyo Cooperative Oncology Group

Institute

Department

Personal name

Organization

The Tokyo Cooperative Oncology Group

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

2008

Year

06

Month

01

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://link.springer.com/journal/10637/33/4?wt_mc=alerts.TOCjournals

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

05

Month

16

Day

Date of IRB

Anticipated trial start date

2008

Year

06

Month

01

Day

Last follow-up date

2012

Year

12

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2008

Year

04

Month

23

Day

Last modified on

2015

Year

07

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001374