UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Response Rate of Bevacizumab and FOLFOXIRI with pegfilgrastim in RAS-mutant type unresectable metastatic colorectal cancer.
Title of the study (Brief title)	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	Shigemi Matsumoto
Organization	Kyoto University Hospital
Division name	Department of Medical Oncology
Address	54 Syogoinkawara-cho, Sakyo-ku, Kyoto
TEL	075-751-4349
Email	motocame@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Akira Nozaki
Organization	NHO Kyoto Medical Center
Division name	Department of Clinical Oncology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 07 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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