Unique ID issued by UMIN | UMIN000018187 |
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Receipt number | R000020992 |
Scientific Title | Response Rate of Bevacizumab and FOLFOXIRI with pegfilgrastim in RAS-mutant type unresectable metastatic colorectal cancer. |
Date of disclosure of the study information | 2015/07/31 |
Last modified on | 2019/01/03 12:44:09 |
Response Rate of Bevacizumab and FOLFOXIRI with pegfilgrastim
in RAS-mutant type unresectable metastatic colorectal cancer.
Revital Trial
Response Rate of Bevacizumab and FOLFOXIRI with pegfilgrastim
in RAS-mutant type unresectable metastatic colorectal cancer.
Revital Trial
Japan |
metastatic colorectal cancer
Medicine in general | Gastroenterology | Hematology and clinical oncology |
Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Malignancy
NO
We confirms the efficacy and safety of FOLFOXIRI + Bevacizumab therapy with Pegfilgrastim in RAS-mutant type unresectable metastatic colorectal cancer.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
ORR: overall response rate
PFS: progression free survival, safety, R0 resection rate, Pathological response rate, OS:Overall survival, Treatment completion rate, RDI: relative dose intensity, ETS:Early Tumor Shrinkage
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Biweekly FOLFOXIRI+Bevacizumab +Pegfilgrastim
Bevacizumab 5mg/kg/ q2w
Oxaliplatin 85mg/m2/ q2w
Irinotecan 165mg/m2/ q2w
l-LV 200mg/m2/ q2w
5FU-infusional 3,200mg/m2/ q2w
Pegfilgrastim 3.6mg / q2w
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1.Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum and
inoperable metastatic disease
2.RAS mutant type
3.No Previous chemotherapy for colorectal cancer except adjuvant treatment if terminated more than 6 months before the start of study treatment
4.Unresectable liver metastases
5.Presence of a measurable index lesion(RECIST v1.1)
6.Age: between 20 and 75 years
7.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1 at study entry (patients above 70 years of age are eligble if their ECOG PS score is 0)
8.Adequate organ functions
1)WBC;3,000-12,000/mm3
2)ANC: greater than or equql to 1,500/mm3
3)Platelet: greater than or equql to 100,000/mm3
4)Hb: greater than or equql to 9.0g/dl
5)T-bil:less than or equal to 1.5 times the upper limit of normal (ULN)
6)aspartate transaminase (AST) or alanine transaminase (ALT) levels less than or equal to 2.5 times the ULN
7)serum creatinine level less than or equal to 1.5 times the ULN
8)Proteinuria below Gr1 (in the case of 2+ in the test paper method, registration possible in the case of proteinuria 1g <24 hours)
9.Life expectancy of at least 3 months
10.Provided signed written informed consent.
11.UGT1A1 *6*28 wild type or single hetero
12.No extrahepatic metastasis, or
it can be determined to be curative
even if extrahepatic metastases (lung metastasis PUL1 etc.)
1.Severe infection
2.Neuropathy >= Grade 2 according to the CTCAE
3.Prior hypersensitivity reaction to drugs useing in this trial
4.Dementia, altered mental status, or any psychiatric condition
5.Uncontrolled body fruid (ascites,pleural effusion.pericardiac effsion)
6.Severe stenotic primary lesion
7.Recieved radiotherapy to target lesion
8.Severe comorbidity (paralytic or mechanical bowel obstruction, interstitial pneumonia, pulmonary fobrosis, uncontrolable diabetes, heart failure,hypertension, renal failure, liver failure,thromboembolic disease, cerebrovascular disease, etc.)
9.Current or previous (within the last 1 year) history of GI perforation
10.HBs-Ag(+)
11.Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery except for CV-port procedure within 28 days
12.Active other malignant disease
13.Symptomatic brain metastasis
14.Uncontroled severe diarrhea
15.Past chemotherapy history by cytotoxic agent for other diseases except hormone agents and molecular target drugs
16.Women's pregnant or nursing, men/women who want to give birth or no intention to contraception
17.Any other cases who are regarded as inadequate for study enrollment by investigators.
40
1st name | |
Middle name | |
Last name | Shigemi Matsumoto |
Kyoto University Hospital
Department of Medical Oncology
54 Syogoinkawara-cho, Sakyo-ku, Kyoto
075-751-4349
motocame@kuhp.kyoto-u.ac.jp
1st name | |
Middle name | |
Last name | Akira Nozaki |
NHO Kyoto Medical Center
Department of Clinical Oncology
1-1 Fukakusa mukaiha-cho Fushimi-ku, Kyoto
075-641-9161
anozaki@kyotolan.hosp.go.jp
Kyoto University Hospital
Kyoto University Hospital
Self funding
NO
京都大学医学部附属病院
京都民医連中央病院
大津赤十字病院
大阪赤十字病院
京都桂病院
高槻赤十字病院
倉敷中央病院
神戸市立医療センター中央市民病院
2015 | Year | 07 | Month | 31 | Day |
Unpublished
Terminated
2015 | Year | 07 | Month | 23 | Day |
2015 | Year | 08 | Month | 07 | Day |
2015 | Year | 07 | Month | 03 | Day |
2019 | Year | 01 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020992
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