UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005572 |
|---|---|
| Receipt number | R000006593 |
| Scientific Title | A phase II study of Perioperative FOLFOX4 plus Bevacizumab for initially unresectable Advanced Colorectal Cancer. |
| Date of disclosure of the study information | 2011/05/09 |
| Last modified on | 2016/02/16 11:03:19 |
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Basic information
Public title
A phase II study of Perioperative FOLFOX4 plus Bevacizumab for initially unresectable Advanced Colorectal Cancer.
Acronym
Neoadjuvant and Adjuvant Investigating Team of CRC-01 (NAVIGATE-CRC-01)
Scientific Title
A phase II study of Perioperative FOLFOX4 plus Bevacizumab for initially unresectable Advanced Colorectal Cancer.
Scientific Title:Acronym
Neoadjuvant and Adjuvant Investigating Team of CRC-01 (NAVIGATE-CRC-01)
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of perioperative FOLFOX4 plus Bevacizumab for initially unresectable advanced Colorectal Cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Completion rate of neoadjuvant chemotherapy.
Possibility of curative surgery.
Key secondary outcomes
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
FOLFOX4+Bevacizumab
5FU bolus: 400 mg/m2 d1,2
5FU infusion: 600 mg/m2/22h d1,2
Oxaliplatin: 85mg/m2 d1
l-LV: 100mg/m2 d1,2
bevacizumab: 5mg/kg d1
Bevacizumab 5mg/m2 d1
Q2w
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Written informed consent
2. Age 20-74 years old.
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
4. Life expectancy greater than or equal to 3 months
5. Histological confirmation of colorectal cancer.
6. Previously untreated advanced colon or rectal (Rs-Ra) cancer.
7. Vital organ functions (listed below) are preserved within 2 weeks prior to entry.
i. Neurtophils =or>1500/mm3
ii. Platelets =or<100,000/mm3
iii. Hemoglobin=or>9.0g/dl
iv. AST and ALT =or<upper limit of normal (ULN)x2.5 (=or<ULNx5 in case of liver metastasis)
v. Total bilirubin =or<upper limit of normal (ULN)x1.5
vi. Serum creatinine =or<upper limit of normal (ULN)x1.5
8. Initially considered as unresectable advanced colorectal Cancer.
Key exclusion criteria
1. Malignant coelomic fluid.
2. Radiological evidence of CNS metastases or brain cancer.
3. Multiple primary cancer within 5 years.
4. Complication of cerebrovascular disease or symptoms within 1 year.
5. Any surgical treatments including skin open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week.
6. Planned surgery during chemotherapy.
7. Administering antithrombotic drug within 10 days.
8. Need to administrate or having anti-platelets therapy (including Methotrexate aspirin and NSAIDS).
9. Evidence of bleeding diathesis or coagulopathy.
10. Active gastrointestinal ulcer
11. Current or previous (within the last 1 year) history of GI perforation
12. Non healing fracture
13. Renal failure to be treated, 2+ or higher proteinuria within 2 weeks prior to entry
14. Uncontrolled Hypertension
15. Clinically significant (i.e. active) cardiovascular disease, or past or current history (within the last 1 year) of myocardial infarction
16. History of the serious hypersensitivity for Fluorouracil, leucovorin calcium or platinum agents.
17. Dihydropyrimidine Dehydrogenase Deficiency.
18. Uncontrolled diarrhea.
19. Evidence of interstinal lung disease, or pulmonary fibrosis.
20. Evidence of peripheral neuropathy.
21. CV access system implanted within 7 days before chemotherapy.
22. History of organ transplantation
23. Uncontrolled Active infection.
24. Other conditions not suitable for this study.
Target sample size
49
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Mizunuma |
Organization
The cancer institute hospital of JFCR
Division name
Gastroenterology center
Zip code
Address
135-8550, 3-8-31 Ariake Koto-ku Tokyo
TEL
+81-3-3520-0111
mizunuma@jfcr.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsukuni Suenaga |
Organization
The cancer institute hospital of JFCR
Division name
Gastroenterology center
Zip code
Address
135-8550, 3-8-31 Ariake Koto-ku Tokyo
TEL
+81-3-3520-0111
Homepage URL
m.suenaga@jfcr.or.jp
Sponsor or person
Institute
Japanese foundation for cancer research
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
がん研有明病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Terminated
Date of protocol fixation
| 2007 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 09 | Day |
Last modified on
| 2016 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006593
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