UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Multinational, Randomized, Phase III Study of XELIRI with/without Bevacizumab versus FOLFIRI with/without Bevacizumab as Second-line Therapy in Patients with Metastatic Colorectal Cancer.
Title of the study (Brief title)	Asian XELIRI Project (AXEPT): non-inferiority study of FOLFIRI with/without Bevacizumab vs. XELIRI with/without Bevacizumab as 2nd-line therapy in patients with mCRC
Region	Japan Asia(except Japan)

Condition
Condition	Patients with 2nd-line treatment of mCRC
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To demonstrate the non-inferiority of XELIRI with or without Bevacizumab compared with FOLFIRI with or without Bevacizumab as 2nd-line treatment in patient with metastatic colorectal cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Overall Survival
Key secondary outcomes	PFS, TTF, ORR, DCR, RDI, Safety, Correlation between UGT1A1 polymorphisms and Safety

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Arm A: FOLFIRI +/- Bevacizumab (CPT-11:180 mg/m2)
Interventions/Control_2	Arm B: Tri-weekly XELIRI +/- Bevacizumab (CPT-11: 200 mg/m2, Capecitabine: 1600 mg/m2/day x14 days)
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) Histologically-confirmed inoperable colorectal adenocarcinoma excluding vermiform appendix cancer and anal canal cancer. 2) Age >=20 years at the time of informed consent 3) ECOG PS of 0-2 4) Written informed consent 5) Life expectancy of at least 90 days 6) Withdrawal from first-line chemotherapy(regardless of containing molecular-targeted drugs)for metastatic colorectal cancer due to intolerable toxicity or progressive disease, or relapse within 180 days after the last dose of adjuvant chemotherapy. 7) Adequate organ function according to following laboratory values obtained within 14 days before enrolment(excluding patients who received blood transfusions or hematopoietic growth factors within 14 days before the laboratory test)
Key exclusion criteria	1)Contraindications of each protocol drugs 2)History of other malignancy with a disease-free survival<5 years 3)Radiological evidence of brain tumor or brain metastases 4)Active infection including hepatitis 5)Previous treatment with irinotecan hydrochloride 6)Pregnant or lactating females, and males and females unwilling to use contraception 7)Requires continuous treatment with systemic steroids 8)Psychiatric disability that would preclude study compliance 9)Otherwise determined by the investigator to be unsuitable for participation in the study <In case of combination with Bevacizumab> 10)Concurrent or recent (within 1 year before enrollment) gastrointestinal perforation 11)Unhealed wound, gastrointestinal ulcer, or traumatic fracture 12)Current or recent(within 1 year before enrollment)thromboembolism or cerebrovascular disease 13)Uncontrolled hypertension 14)Urine dipstick for proteinuria>+2
Target sample size	600

Research contact person
Name of lead principal investigator	Kei Muro
Organization	Aichi Cancer Centre Hospital, Japan
Division name	Gastrointestinal Medical Oncology Division
Address	1-1 Kanokoden, Chikusa-ku Nagoya 464-8681, JapanJapan
TEL	+81-52-762-6111
Email	kmuro@aichi-cc.jp

Public contact
Name of contact person	Yumi Miyashita
Organization	NPO Epidemiological and Clinical Research Information Network (ECRIN)
Division name	Aichi Branch
Address	Sanshuya Builfing 3F,348 Kousei-cho,Okazaki City,Aichi Prefecture 444-0052,Japan
TEL	0564-66-1220
Homepage URL
Email	axept@ecrin.or.jp

Sponsor
Institute	NPO Epidemiological and Clinical Research Information Network (ECRIN)
Institute
Department

Funding Source
Organization	CHUGAI PARMACEUTICAL CO., LTD
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	（日本） 愛知県がんセンター中央病院（愛知県） 独立行政法人　国立がん研究センター中央病院　（東京都） 国家公務員共済組合連合会　虎の門病院　（東京都） 横浜市立大学附属市民総合医療センター　（神奈川県） 社会医療法人財団 慈泉会 相澤病院　（長野県） 公立学校共済組合　東海中央病院　（岐阜県） 松下記念病院　（大阪府） 大阪医科大学附属病院　（大阪府） 医療法人薫風会　佐野病院　（兵庫県） 九州厚生年金病院　（福岡県） （韓国） Asan Medical Centre, South Korea Samsung Medical Centre, South Korea （中国） Sun Yat-Sen University Cancer Centre, China

Other administrative information
Date of disclosure of the study information	2013 Year 11 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 03 Day
Anticipated trial start date	2013 Year 12 Month 02 Day
Last follow-up date	2017 Year 05 Month 31 Day
Date of closure to data entry	2017 Year 09 Month 06 Day
Date trial data considered complete	2017 Year 09 Month 06 Day
Date analysis concluded	2017 Year 11 Month 16 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://dx.doi.org/10.1016/S1470-2045(18)30140-2
Results
Other related information

Management information
Registered date	2013 Year 11 Month 11 Day
Last modified on	2019 Year 02 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014333