UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001490 |
|---|---|
| Receipt number | R000001786 |
| Scientific Title | Multicenter phase II study of modified FOLFOX6 and bevacizumab in chemonaive advanced or recurrent colorectal cancer. |
| Date of disclosure of the study information | 2008/11/10 |
| Last modified on | 2014/01/08 13:16:45 |
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Basic information
Public title
Multicenter phase II study of modified FOLFOX6 and bevacizumab in chemonaive advanced or recurrent colorectal cancer.
Acronym
PROMETEUS I
Scientific Title
Multicenter phase II study of modified FOLFOX6 and bevacizumab in chemonaive advanced or recurrent colorectal cancer.
Scientific Title:Acronym
PROMETEUS I
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate the efficacy and safety of mFOLFOX6 plus Bevacizumab in chemonaive advanced or recurrent colorectal cancer.
Basic objectives2
Others
Basic objectives -Others
Exploration of biomarkers such as genomic, proteomic, and metabolomic expression profiling to discriminate the response.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Efficacy: Response rate
Key secondary outcomes
Efficacy: Progression free survival:PFS,Time to treatment failure:TTF,Time to failure of strategy:TFS,Overall survival:OS,Safety: Adverse events, Duration of peri-pheral neuropathyBiomarker, such as genomic, proteomic, and metabolomic expression, profiling to discriminate the response to the treatment from patients' blood samples.
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
Patients receive modified FOLFOX6 with bevacizumab (Treatment will be continued to 24 cycles unless the disease progression, unacceptable toxicity, or consent withdrawal.).
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.Histologically confirmed adenocarcinoma of the colon or rectum.
2.Unresectable or recurrent colorectal cancer patient.
3.At least one unidimensionally measurable lesion.
4.No prior chemotherapy, immunotherapy, and radiotherapy.
5.Aged 20<= years.
6.Eastern Cooperative Oncology Group (ECOG) performance status of 1>=.
7.Life expectancy at least 3 months.
8.Adequate bone marrow, heart, pulmonary, liver, and renal function.
9.Written informed consent
Key exclusion criteria
Patient with contraindication to oxaliplatin, 5-FU, l-LV, or Bevacizumab.
Target sample size
65
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kei Muro |
Organization
Aichi Cancer Center
Division name
Department of Clinical Oncology
Zip code
Address
1-1 Kanokoden, Chikusa-ku, 464-8681, Nagoya
TEL
052-762-6111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirohiko Maeda |
Organization
Yakult Honsha Co.,Ltd.
Division name
Pharmaceutical Development Department, Post Marketing Development Section
Zip code
Address
3F Ginza-Kobiki Bldg.,16-21,Ginza 7-chome,Chuo-ku,Tokyo,104-0061 Japan
TEL
03-5550-8962
Homepage URL
hirohiko-maeda@yakult.co.jp
Sponsor or person
Institute
Yakult Honsha Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Yakult Honsha Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2008 | Year | 11 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2008 | Year | 08 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 10 | 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 | 11 | Month | 09 | Day |
Last modified on
| 2014 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001786
