Unique ID issued by UMIN | UMIN000002557 |
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Receipt number | 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 08:21:14 |
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.
Phase III study of Bevacizumab 5mg/kg or 10mg/kg to FOLFIRI in advanced CRC who have failed prior Bevacizumab plus Oxaliplatin-based therapy.
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.
Phase III study of Bevacizumab 5mg/kg or 10mg/kg to FOLFIRI in advanced CRC who have failed prior Bevacizumab plus Oxaliplatin-based therapy.
Japan |
advanced colorectal cancer
Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
Hematology and clinical oncology | Surgery in general | Gastrointestinal surgery |
Hepato-biliary-pancreatic surgery |
Malignancy
NO
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.
Safety,Efficacy
Confirmatory
Pragmatic
Phase III
progression free survival
>Overall survival
>Overall survival from first line Second progression free survival (progression free survival from first line)
>Response rate
>Time to treatment failure
>Safety
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
FOLFIRI plus bevacizumab 5mg/kg is treated until progression.
FOLFIRI plus bevacizumab 10mg/kg is treated until progression.
20 | years-old | <= |
Not applicable |
Male and Female
(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
(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
370
1st name | |
Middle name | |
Last name | Hideyuki Mishima |
Aichi Medical University
Cancer Center
1-1, Yazakokarimata, Nagakute, Aichi
0561-62-3311
hmishima@aichi-med-u.ac.jp
1st name | |
Middle name | |
Last name | Chigusa Abe |
Epidemiological and Clinical research Information Network (ECRIN)
Data Center
21-7 Shogoinn Sakyo-ku, Kyoto
075-762-1227
chigusa.abe@ecrin.or.jp
Epidemiological and Clinical research Information Network (ECRIN)
Epidemiological and Clinical research Information Network (ECRIN)
Non profit foundation
NO
2009 | Year | 09 | Month | 30 | Day |
Published
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.
Completed
2009 | Year | 07 | Month | 28 | Day |
2009 | Year | 10 | Month | 01 | Day |
2013 | Year | 09 | Month | 01 | Day |
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
2009 | Year | 09 | Month | 28 | Day |
2018 | Year | 09 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003077
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