UMIN-CTR Clinical Trial

Basic information
Public title	A phase II trial of oxaliplatin, capecitabine, irinotecan (XELOXIRI) and bevacizumab as first-line therapy for patients with metastatic colorectal cancer
Acronym	Phase II study of XELOXIRI+Bevacizumab
Scientific Title	A phase II trial of oxaliplatin, capecitabine, irinotecan (XELOXIRI) and bevacizumab as first-line therapy for patients with metastatic colorectal cancer
Scientific Title:Acronym	Phase II study of XELOXIRI+Bevacizumab
Region	Japan

Condition
Condition	metastatic colorectal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate efficacy and safety of CPT-11 + L-OHP + capecitabine + Bevacizumab therapy for metastatic colorectal cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Progression-free survival
Key secondary outcomes	Overall survival, response rate, safety, R0 resection rate, efficacy by the RAS mutation status, QOL

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	irinotecan, oxaliplatin, capecitabine, bevacizumab
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. Histologically confirmed advanced metastatic/recurrent colorectal cancer. 2. No prior chemotherapy except adjuvant chemotherapy if completed more than 6months prior to enrollment. 3. Age :20-75 years 4. Wild or hetero type of UGT1A1*28 or *6 genotype 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2. 6. Vital organ functions (listed below) are preserved within a week prior to entry. 7. Survival more than 3 months. 8. Written informed consent.
Key exclusion criteria	1. Need to drain malignant fluid. 2. With a history of allergic response to Fluorouracil or Levofolinate calcium or Platinium. 3. Pregnant or lactating women or women of childbearing potential. 4. Uncontrolled infection. 5. Evidence of interstinal lung disease, or pulmonary fibrosis. 6. Clinically significant (i.e. active) cardiovascular disease or past or current history (within the last 1 year) of myocardial infarction. 7. Uncontrollable ulcer indigestive tract. 8. Radiological evidence of CNS metastases or brain cancer. 9. Complication of cerebrovascular disease or symptoms within 1 year. 10. Any surgical treatments within 4 weeks. 11. Administering antithrombotic drug within 10 days. Need to administrate or having anti-platelets therapy 12. Multiple primary cancers within 5 years. 13. Other conditions not suitable for this study.
Target sample size	47

Research contact person
Name of lead principal investigator	1st name Ohnuma Middle name Last name Hiroyuki
Organization	Sapporo Medical University School of Medicine
Division name	Department of Medical Oncology
Zip code	060-0061
Address	S-1, W-16, Chuo-ku, Sapporo
TEL	011-611-2111
Email	ohnuma@sapmed.ac.jp

Public contact
Name of contact person	1st name Ohnuma Middle name Last name Hiroyuki
Organization	Sapporo Medical University School of Medicine
Division name	Department of Medical Oncology
Zip code	060-0061
Address	S-1, W-16, Chuo-ku, Sapporo
TEL	011-611-2111
Homepage URL
Email	ohnuma@sapmed.ac.jp

Sponsor
Institute	Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization	Self funding
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	Clinical trial center, Sapporo Medical University
Address	S-1, W-16, Chuo-ku, Sapporo
Tel	011-611-2111
Email	kenkyusien@sapmed.ac.jp

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	2020 Year 03 Month 12 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	Open public recruiting
Date of protocol fixation	2014 Year 11 Month 20 Day
Date of IRB	2014 Year 12 Month 17 Day
Anticipated trial start date	2014 Year 12 Month 22 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 03 Month 12 Day
Last modified on	2020 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045372