UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003477 |
|---|---|
| Receipt number | R000004207 |
| Scientific Title | Randomized phase 2 study of mFOLFOX6 plus bevacizumab versus modified OPTIMOX plus bevacizumab for metastatic colorectal cancer |
| Date of disclosure of the study information | 2010/04/12 |
| Last modified on | 2017/04/17 13:38:04 |
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Basic information
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
Condition
colorectal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
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
Assessment
Primary outcomes
disease control survival
Key secondary outcomes
Progression-free survival
Overall survival
The incidence of adverse events
Base
Study type
Interventional
Study design
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
Intervention
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
Eligibility
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
Research contact person
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
tdenda@chiba-cc.jp
Public contact
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
tdenda@chiba-cc.jp
Sponsor or person
Institute
Chiba Cancer Center Hospital
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
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
| 2010 | Year | 04 | Month | 12 | 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
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
Other related information
Management 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
