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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001817
Receipt No. R000002193
Scientific Title Multicenter phase II study of FOLFIRI and bevacizumab as second-line treatment in advanced or recurrent colorectal cancer.
Date of disclosure of the study information 2009/04/01
Last modified on 2014/01/08

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Basic information
Public title Multicenter phase II study of FOLFIRI and bevacizumab as second-line treatment in advanced or recurrent colorectal cancer.
Acronym PROMETEUSII
Scientific Title Multicenter phase II study of FOLFIRI and bevacizumab as second-line treatment in advanced or recurrent colorectal cancer.
Scientific Title:Acronym PROMETEUSII
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 FOLFIRI plus Bevacizumab as second-line treatment in 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
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Efficacy: Response rate
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 Patients receive FOLFIRI with bevacizumab (Treatment will be continued 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.Administered FOLFOX treatment as first-line chemotherapy
4.Diagnosed no mutation or heterozygosity by genotyping assay
5.At least one unidimensionally measurable lesion.
6.Aged >= 20 years.
7.Eastern Cooperative Oncology Group (ECOG) performance status of =<1.
8.Life expectancy at least 3 months.
9.Adequate bone marrow, heart, pulmonary, liver, and renal function.
10.Written informed consent
Key exclusion criteria Patient with contraindication to Irinotecan, 5-FU, l-LV, or Bevacizumab.
Target sample size 90

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
Email

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
Email hirohiko-maeda@yakult.co.jp

Sponsor
Institute Yakult Honsha Co.,Ltd.
Institute
Department

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
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
2009 Year 04 Month 01 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 12 Month 25 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2012 Year 03 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
2009 Year 03 Month 30 Day
Last modified on
2014 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002193

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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