UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012263 |
|---|---|
| Receipt number | 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 13:33:58 |
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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
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
axept@ecrin.or.jp
Sponsor or person
Institute
NPO Epidemiological and Clinical Research Information Network (ECRIN)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014333
