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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000018187
Receipt No. 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

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Basic information
Public title Response Rate of Bevacizumab and FOLFOXIRI with pegfilgrastim
in RAS-mutant type unresectable metastatic colorectal cancer.
Acronym Revital Trial
Scientific Title Response Rate of Bevacizumab and FOLFOXIRI with pegfilgrastim
in RAS-mutant type unresectable metastatic colorectal cancer.
Scientific Title:Acronym Revital Trial
Region
Japan

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

Objectives
Narrative objectives1 We confirms the efficacy and safety of FOLFOXIRI + Bevacizumab therapy with Pegfilgrastim in RAS-mutant type unresectable metastatic colorectal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes ORR: overall response rate
Key secondary outcomes 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

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 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
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.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.)
Key exclusion criteria 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.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigemi Matsumoto
Organization Kyoto University Hospital
Division name Department of Medical Oncology
Zip code
Address 54 Syogoinkawara-cho, Sakyo-ku, Kyoto
TEL 075-751-4349
Email motocame@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Nozaki
Organization NHO Kyoto Medical Center
Division name Department of Clinical Oncology
Zip code
Address 1-1 Fukakusa mukaiha-cho Fushimi-ku, Kyoto
TEL 075-641-9161
Homepage URL
Email anozaki@kyotolan.hosp.go.jp

Sponsor
Institute Kyoto University Hospital
Institute
Department

Funding Source
Organization Kyoto University Hospital
Organization
Division
Category of Funding Organization Self funding
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 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

Other administrative information
Date of disclosure of the study information
2015 Year 07 Month 31 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
2015 Year 07 Month 23 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 07 Month 03 Day
Last modified on
2019 Year 01 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020992

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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