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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001127
Receipt No. R000001374
Scientific Title Phase II study of Bevacizumab plus modified OPTIMOX1 in patients with unresectable advanced/recurrent colorectal cancer
Date of disclosure of the study information 2008/06/01
Last modified on 2015/07/09

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Basic information
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
Condition Unresectable advanced/recurrent colorectal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
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

Assessment
Primary outcomes Duration of disease control
Key secondary outcomes Safety
Reintroduction rate
Overall response rate
Overall survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute The Tokyo Cooperative Oncology Group
Institute
Department

Funding Source
Organization The Tokyo Cooperative Oncology Group
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
2008 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
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

Progress
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
Other related information

Management information
Registered date
2008 Year 04 Month 23 Day
Last modified on
2015 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001374

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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