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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002557
Receipt No. R000003077
Scientific Title Multicenter randomized phase III study of adding Bevacizumab 5mg/kg or 10mg/kg to FOLFIRI in advanced colorectal cancer who have failed prior Bevacizumab plus Oxaliplatin-based therapy.
Date of disclosure of the study information 2009/09/30
Last modified on 2018/09/20

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Basic information
Public title Multicenter randomized phase III study of adding Bevacizumab 5mg/kg or 10mg/kg to FOLFIRI in advanced colorectal cancer who have failed prior Bevacizumab plus Oxaliplatin-based therapy.
Acronym Phase III study of Bevacizumab 5mg/kg or 10mg/kg to FOLFIRI in advanced CRC who have failed prior Bevacizumab plus Oxaliplatin-based therapy.
Scientific Title Multicenter randomized phase III study of adding Bevacizumab 5mg/kg or 10mg/kg to FOLFIRI in advanced colorectal cancer who have failed prior Bevacizumab plus Oxaliplatin-based therapy.
Scientific Title:Acronym Phase III study of Bevacizumab 5mg/kg or 10mg/kg to FOLFIRI in advanced CRC who have failed prior Bevacizumab plus Oxaliplatin-based therapy.
Region
Japan

Condition
Condition advanced colorectal cancer
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Hematology and clinical oncology Surgery in general Gastrointestinal surgery
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Multicenter randomized phase III study of adding Bevacizumab 5mg/kg or 10mg/kg to FOLFIRI in advanced colorectal cancer who have failed prior Bevacizumab plus Oxaliplatin-based therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes progression free survival
Key secondary outcomes >Overall survival
>Overall survival from first line Second progression free survival (progression free survival from first line)
>Response rate
>Time to treatment failure
>Safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 FOLFIRI plus bevacizumab 5mg/kg is treated until progression.

Interventions/Control_2 FOLFIRI plus bevacizumab 10mg/kg is treated until progression.
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) Disease progression(PD) or difficult to continue for other reason after chemotherapy with bevacizumab as 1st line Oxaliplatin containing regimen
(with measurable lesions in RECIST criteria)
(2) Oxaliplatin and bevacizumab were administrated for more than 4 times in 1stline
(3) Colorectal cancer, cytologically and/or histrogically
(4) Written informed consents
(5) Age: 20 years old and above
(6) Performance Status(ECOG):0~1
(7) Life expectancy estimated >= 3 months
(8) Sufficient organ functions




Key exclusion criteria (1) Previously irinotecan treatment
(2) Administering transfusion/ hematopoietic factor or antithrombotic drug within 14 days
(3) Serious renal dysfunction
(4) Serious drug hypersensitivity or a history of drug allergy
(5) Active concomitant malignancy
(6) Active infections
(7) Symptomatic or asymptomatic but treated heart disease
(8) History of thrombosis, interstitial pneumonitis, pulmonary fibrosis or high-grade pulmonary emphysema
(9) Fresh hemorrhage from digestive tube, intestines tube paralysis, intestinal obstruction and peptic ulcer
(10) Pleural effusion, peritoneal fluid and pericardial fluid
(11) Symptomatic brain metastasis
(12) History of mental disturbances or cerebrovascular accident
(13) High blood pressure and diabetic that cannot be controlled
(14) Uncontrolled diarrhea
(15) Serious non-healing wound and/or major surgical procedure within 4weeks prior to enroll in this study
(16) Traumatic fracture of unrecovery
(17) Bleeding tendency and anti-platelets therapy (including aspirin and NSAIDS)
(18) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers
(19) Need to treatment with atazanavir sulfate
(20) Paralyzed bowel
(21) Other conditions not suitable for this study

Target sample size 370

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideyuki Mishima
Organization Aichi Medical University
Division name Cancer Center
Zip code
Address 1-1, Yazakokarimata, Nagakute, Aichi
TEL 0561-62-3311
Email hmishima@aichi-med-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chigusa Abe
Organization Epidemiological and Clinical research Information Network (ECRIN)
Division name Data Center
Zip code
Address 21-7 Shogoinn Sakyo-ku, Kyoto
TEL 075-762-1227
Homepage URL
Email chigusa.abe@ecrin.or.jp

Sponsor
Institute Epidemiological and Clinical research Information Network (ECRIN)
Institute
Department

Funding Source
Organization Epidemiological and Clinical research Information Network (ECRIN)
Organization
Division
Category of Funding Organization Non profit foundation
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 09 Month 30 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: 

Three hundred and eighty-seven patients were randomized between September 2009 and January 2012 from 100 institutions in Japan. Baseline patient characteristics were well balanced between the two groups. Efficacy was evaluated
in 369 patients (5 mg/kg, n = 181 and 10 mg/kg, n = 188). Safety was evaluated in 365 patients (5 mg/kg, n = 180
and 10 mg/kg, n = 185). The median PFS was 6.1 versus 6.4 months (hazard ratio, 0.95; 95% confidence interval [CI]
0.75-1.21; P = 0.676), and median TTF was 5.2 versus 5.2 months (hazard ratio, 1.01; 95% CI 0.81-1.25; P = 0.967), respectively,for the bevacizumab 5 and 10 mg/kg groups. Follow-up of OS is currently ongoing. Adverse events, including
hypertension and hemorrhage, occurred at similar rates in both groups.
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
2009 Year 07 Month 28 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2013 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Annals of Oncology 26: 1427-1433, 2015

FOLFIRI plus bevacizumab as second-line therapy in patients with metastatic colorectal cancer after firstline bevacizumab plus oxaliplatin-based therapy: therandomized phase III EAGLE study

S. Iwamoto1,, T. Takahashi, H. Tamagawa, M. Nakamura, Y. Munemoto, T. Kato, T. Hata,T. Denda, Y. Morita, M. Inukai, K. Kunieda, N. Nagata, K. Kurachi, K. Ina14, M. Ooshiro,T. Shimoyama, H. Baba, K. Oba, J. Sakamoto & H. Mishima

Management information
Registered date
2009 Year 09 Month 28 Day
Last modified on
2018 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003077

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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