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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012263
Receipt No. R000014333
Scientific Title 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.
Date of disclosure of the study information 2013/11/11
Last modified on 2019/02/22

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Basic information
Public title 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.
Acronym 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
Scientific Title 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.
Scientific Title:Acronym 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
1st name
Middle name
Last name Kei Muro
Organization Aichi Cancer Centre Hospital, Japan
Division name Gastrointestinal Medical Oncology Division
Zip code
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
1st name
Middle name
Last name Yumi Miyashita
Organization NPO Epidemiological and Clinical Research Information Network (ECRIN)
Division name Aichi Branch
Zip code
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)

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 (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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://dx.doi.org/10.1016/S1470-2045(18)30140-2
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
2013 Year 09 Month 03 Day
Date of IRB
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

Other
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

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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