UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010442 |
|---|---|
| Receipt number | R000012210 |
| Scientific Title | Phase I study of FOLFOXIRI+Bev for unresectabl colorecatal cancer |
| Date of disclosure of the study information | 2013/04/08 |
| Last modified on | 2018/10/23 08:29:19 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Phase I study of FOLFOXIRI+Bev for unresectabl colorecatal cancer
Acronym
Phase I study of FOLFOXIRI+Bev for unresectabl colorecatal cancer
Scientific Title
Phase I study of FOLFOXIRI+Bev for unresectabl colorecatal cancer
Scientific Title:Acronym
Phase I study of FOLFOXIRI+Bev for unresectabl colorecatal cancer
Region
| Japan |
Condition
Condition
Unresectable colorectal cancer
Classification by specialty
| Medicine in general | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determinate maximum tolerated dose, dose-limiting toxicity and recommended dose
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
maximum tolerated dose
Key secondary outcomes
recommended dose, response rate, toxicity
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
FOLFOXIRI+Bevacizumab
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Histological proven colorectal cancer
2) Measurable lesions not required
3) ECOG performance status 0-2
4) without any prior chemotherapy, or with prior 5-FU, FOFLOX adjuvant therapy after 6 months of last administration
5) Adequate organ function
6) Expected >12 weeks survival
7) Written informed consent from patient
8) Age>20 or older
Key exclusion criteria
Symptomatic brain metastasis
Sever wattery diarrhea
Paralytic or mechanical bowel obstruction
Confirmed or suspected infection
Severe pulmonary disease (interstitial pneumonia, pulmonary fobrosis, severe emphysematous)
Severe comorbidity (uncontrolable diabetes, heart failure with NYHA 3 or 4, renal failure, liver failure)
Pregnant or possibly pregnant, and nursing women
Sever neurologic disease
Receiving atazanavir sulfate
Past history of monoclonal antibody allergy
Past history of 5-FU/LV allergy
Past history of FOLFOX allergy
Complication of cerebrovascular disease or symptoms within 1 year
Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week
Administering antithrombotic drug within 10 days
Need to administrate or having anti-platelets therapy (including Methotrexate aspirin and NSAIDS)
Evidence of bleeding diathesis or coagulopathy
Active gastrointestinal ulcer
Current or previous (within the last 1 year) history of GI perforation
Non healing fracture
Clinically significant (i.e. active) cardiovascular disease, or past or current history (within the last 1 year) of myocardial infarction
Other conditions not suitable for this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ura Takashi |
Organization
Aichi Cancer Center Hospital
Division name
Department of Clinical Oncology
Zip code
Address
1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Aichi, Japan.
TEL
052-762-6111
tura@aichi-cc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ura Takashi |
Organization
Aichi Cancer Center Hospital
Division name
Department of Clinical Oncology
Zip code
Address
1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Aichi, Japan.
TEL
052-762-6111
Homepage URL
tura@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Aichi Cancer Center Hospital
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 08 | 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
Completed
Date of protocol fixation
| 2013 | Year | 03 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 03 | 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
| 2013 | Year | 04 | Month | 08 | Day |
Last modified on
| 2018 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012210
