UMIN-CTR Clinical Trial

Basic information
Public title	A phase II trial of TAS-102 in combination with cetuximab for patients with RAS wild-type metastatic colorectal cancer refractory to previous anti-EGFR antibodies(WJOG8916G)
Acronym	A phase II trial of TAS-102 in combination with cetuximab for metastatic colorectal cancer patients(WJOG8916G)
Scientific Title	A phase II trial of TAS-102 in combination with cetuximab for patients with RAS wild-type metastatic colorectal cancer refractory to previous anti-EGFR antibodies(WJOG8916G)
Scientific Title:Acronym	A phase II trial of TAS-102 in combination with cetuximab for metastatic colorectal cancer patients(WJOG8916G)
Region	Japan

Condition
Condition	Metastatic RAS wild type colorectal cancer which has become refractory or there was intolerance to chemotherapies (fluoropyrimidine, irinotecan, oxaliplatin) and bevacizumab, and refractory to anti-epidermal growth factor receptor(EGFR) antibodies
Classification by specialty	Gastroenterology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate the efficacy and tolerability of TAS-102 in combination with cetuximab for patients with metastatic RAS wild type colorectal cancer which has become refractory or there was intolerance to chemotherapies (fluoropyrimidine, irinotecan, oxaliplatin) and bevacizumab, and refractory to anti-EGFR antibodies.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	disease control rate
Key secondary outcomes	overall survival , progression free survival , response rate , safety

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	TAS-102 35 mg/m2, orally BID The evening of Day 1 to the morning of Day 6,Evening of Day 8 to the morning of Day 13, every 28 days Cetuximab Initial dose is 400 mg/m2, the subsequent weekly doses are 250 mg/m2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)histopathologically confirmed unresectable or metastatic colorectal adenocarcinoma 2) Wild-type RAS status 3) Measurable disease by response evaluation criteria in solid tumors (RECIST version 1.1) criteria 4) refractory disease or unable to tolerate agents (fluoropyrimidines, irinotecan, oxaliplatin) and antiangiogenic agent (bevacizumab,ramucirumab and aflibercept) , and refractory to anti-EGFR antibodies (cetuximab and panitumumab) 5) No prior TAS-102 6) Patients who have not had major surgery (i.e., thoracotomy or laparotomy) within 4 weeks prior to enrollment. 7) Patients who have not had radiotherapy for bone and/or brain metastases excluding primary colorectal cancer within 2 weeks prior to enrollment 8) Patients who have not had any chemotherapy within 2 weeks prior to enrollment 9) Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 10) An estimated life expectancy of at least 12 weeks after enrollment 11) Is able to take medications orally 12) Patients must have the following adequate organ functions 13) Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria	1) Previous grade 3/4 hypersensitivity reaction to Cmab 2) Another malignancy with less than 5 disease-free years 3) Presence of active local or systemic infection under treatment 4) Positive for Hepatitis B surface antigen 5) Radiographic evidence of severe pulmonary fibrosis or interstitial pneumonia on Computed Tomography 6) Symptomatic brain and/or leptomeningeal metastases which needs treatment 7) Serious complications 8) Clinically significant mental or psychological disorder 9) Patients requiring continuous treatment with systemic steroids 10) Females who are pregnant, breastfeeding, or with a positive pregnancy test or males and females of reproductive potential unwilling to use adequate contraception 11) Patients whose participation in the trial was judged to be inappropriate by the attending doctor
Target sample size	55

Research contact person
Name of lead principal investigator	1st name Middle name Last name Naoki Izawa
Organization	St. Marianna University School of Medicine
Division name	Department of Clinical Oncology
Zip code
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511
TEL	044-977-8111
Email	n2izawa@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Shinichiro Nakamura
Organization	West Japan Oncology Group
Division name	WJOG datacenter
Zip code
Address	Namba Plaza Bldg.304-1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
TEL	06-6633-7400
Homepage URL
Email	datacenter@wjog.jp

Sponsor
Institute	West Japan Oncology Group
Institute
Department

Funding Source
Organization	Merck Serono Co., Ltd.,Taiho Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
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

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 01 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	Completed
Date of protocol fixation	2017 Year 04 Month 28 Day
Date of IRB	2017 Year 06 Month 30 Day
Anticipated trial start date	2017 Year 07 Month 04 Day
Last follow-up date	2021 Year 06 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 05 Month 01 Day
Last modified on	2022 Year 03 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031178