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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004219
Receipt No. R000005070
Scientific Title Phase II trial of FOLFIRI plus Bevacizumab in second-line therapy after progression on bevacizumab with oxaliplatine-based chemotherapy in patients with metastatic colorectal cancer whose KRAS status are investigated.
Date of disclosure of the study information 2010/09/16
Last modified on 2012/03/15

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Basic information
Public title Phase II trial of FOLFIRI plus Bevacizumab in second-line therapy after progression on bevacizumab with oxaliplatine-based chemotherapy in patients with metastatic colorectal cancer whose KRAS status are investigated.
Acronym KOBE BBP(bevacizumab beyond progression) study
Scientific Title Phase II trial of FOLFIRI plus Bevacizumab in second-line therapy after progression on bevacizumab with oxaliplatine-based chemotherapy in patients with metastatic colorectal cancer whose KRAS status are investigated.
Scientific Title:Acronym KOBE BBP(bevacizumab beyond progression) study
Region
Japan

Condition
Condition Recurrent or metastatic colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy and the safety of FOLFIRI plus Bevacizumab in second-line therapy after progression on bevacizumab with oxaliplatine-based chemotherapy in patients with metastatic colorectal cancer whose KRAS status are investigated.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Overall response rate
Key secondary outcomes safety, resection rate of metastatic lesion, time to treatment-failure, progression free survival, overall survival, overall survival from first- line

overall response rate,
safety, resection rate of metastatic lesion, time to treatment-failure, progression free survival, overall survival, overall survival from first- line in KRAS wild-type and mutant population, respectively

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 Treatment is administered every 2 weeks until evidence of progression, unacceptable toxicity or patient refusal.
During the treatment, image assessment is repeated every 2 months at least.
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.histologically proven unresectable metastatic colorectal cancer
2.at least one measurable leasion (CT and/or MRI, with maximum axis 20mm or more in case of 10mm slice or less, with maximum axis 10mm or more in case of 5mm slice or less)
3.refractory for oxaliplatin-based 1st line chemotherapy. Within 28 days after confirmation of disease progression in 1st line treatment.
4.KRAS status is investigated
5.age: 20-75 years old
6.ECOG PS: 0-2
7.adequate major organ functions
8.expected 3 months or over survival
9.written informed consents
Key exclusion criteria 1.clinical or radiological evidence of CNS metastases
2.current or previous (at least once within the last 1 year/ twice or more) history of arterial thromboembolism such as cerebrovascular disease
3.major surgical procedure, open biopsy or significant traumatic injury except for CV-port procedure within 28 days prior to enrollment/ fine-needle aspiration cytology within 7 days prior to enrollment
4.serious non-healing fracture
5.current or previous (within the last 1 year) history of GI perforation
6.evidence of bleeding diathesis, coagulopathy or abnormal coagulation factor (PT-INR>=1.5 within 14 days prior to enrollment)
7.current or recent (within 10 days prior to enrollment) ongoing treatment with anticoagulants for therapeutic purposes
8.ongoing treatment with aspirin (>= 325 mg/day), nonsteroid anti-inflammatory drug or adrenocortical steroid
9.clinically significant (i.e. active) cardiovascular disease (NCI-CTCAE grade 2 or worse), or past or current history (at least once within the last 1 year/ twice or more) of myocardial infarction
10.renal failure need to treat
11.serious complication (uncontrolled ulcer, hypertension, diabetes mellitus, infection, diarrhea,etc)
12.uncontrolled pleural effusion and/or ascites
13.past or current history (within the last 5 years) of malignant disease, except for the early cancer healed clearly
14.interstitial lung disease, or pulmonary fibrosis
15.history of organ transplantation
16.pregnancy, lactation and positive serum pregnancy test/no birth-control
17.serious drug hypersensitivity or history of drug allergy of 5-FU, l-LV and/or irinotecan
18.history of adverse reaction to fluorouracil in which DPD deficiency is suspected
19.any other cases who are regarded as inadequate for trial enrollment by the investigator
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Tsuda
Organization Hyogo Cancer Center
Division name Dept. of Gastrointestinal and Hepatobiliary Oncology
Zip code
Address Kitaozi-chou 13-70, Akashi, 673-8558
TEL 078-929-1151
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masanori Toyoda
Organization Sano Hospital
Division name Gastrointestinal Center
Zip code
Address Shimizugaoka 2-5-1, Tarumi-ku, Kobe, 655-0031
TEL 078-785-1000
Homepage URL
Email masanoritoyo@hotmail.co.jp

Sponsor
Institute Hyogo Cancer Center, Dept. of Gastrointestinal and Hepatobiliary Oncology
Institute
Department

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
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
2010 Year 09 Month 16 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 Terminated
Date of protocol fixation
2009 Year 10 Month 26 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
2013 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
2012 Year 03 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 09 Month 15 Day
Last modified on
2012 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005070

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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