UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026527 |
|---|---|
| Receipt number | R000030459 |
| Scientific Title | Randomized phase II study of FOLFIRI plus ramucirumab versus FOLFOXIRI plus ramucirumab as first-line treatment in patients with metastatic colorectal cancer(WJOG9216G) |
| Date of disclosure of the study information | 2017/03/24 |
| Last modified on | 2024/09/17 13:03:28 |
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Basic information
Public title
Randomized phase II study of FOLFIRI plus ramucirumab versus
FOLFOXIRI plus ramucirumab as first-line treatment in patients
with metastatic colorectal cancer(WJOG9216G)
Acronym
Randomized phase II study of FOLFIRI plus ramucirumab versus
FOLFOXIRI plus ramucirumab as first-line treatment in patients
with metastatic colorectal cancer(WJOG9216G, RECAST)
Scientific Title
Randomized phase II study of FOLFIRI plus ramucirumab versus
FOLFOXIRI plus ramucirumab as first-line treatment in patients
with metastatic colorectal cancer(WJOG9216G)
Scientific Title:Acronym
Randomized phase II study of FOLFIRI plus ramucirumab versus
FOLFOXIRI plus ramucirumab as first-line treatment in patients
with metastatic colorectal cancer(WJOG9216G, RECAST)
Region
| Japan |
Condition
Condition
first-line treatment in patients
with metastatic colorectal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of FOLFIRI plus ramucirumab (Rmab) treatment and FOLFOXIRI plus Rmab treatment and to select the most promising treatment as the trial therapy used in the upcoming phase III trial
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Objective response rate
Key secondary outcomes
Overall survival,progression-free survival,time to treatment failure, time to second progression or death, early tumor shrinkage, depth of response, R0 resection rate, 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
Dynamic allocation
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Arm A: FOLFIRI+Rmab treatment
Rmab:8 mg/kg/day1
l-leucovorin (l-LV):200 mg/m2/day1
irinotecan (IRI): 180 mg/m2/day1
bolus 5-FU:400 mg/m2/day1
infusional 5-FU:2400 mg/m2/day1-3
Every 2 eeks
Interventions/Control_2
Arm B: FOLFOXIRI+Rmab treatment
Induction therapy: 8 courses (maximum of 12 courses)
Rmab:8 mg/kg/day1
IRI:165 mg/m2/day1
l-LV:200 mg/m2/day1
oxaaliplatin (OX):85 mg/m2/day1
infusional 5-FU: 3200 mg/m2/day1-3
Every 2 weeks
Maintenance therapy
5-FU/l-LV+Rmab, every 2 week
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 or cytologically diagnosed adenocarcinoma of the colon or rectum (excluding the appendix and anal canal).
2) Tumor is clinically determined to be unresectable for a radical cure.
3) Age of 20-75 years.
4) ECOG PS of 0-1 (a PS 0 is required for subjects aged 71-75 years).
5) Measurable lesion according to RECIST, version 1.1.
6) No history of chemotherapy (however, subjects may register if they have received adjuvant chemotherapy with fluoropyrimidine monotherapy and the cancer recurrence occurred >=24 weeks after the last dose. Patients who have received OX-based adjuvant chemotherapy may not register.)
7) Retained organ function.
8) UGT1A1 gene status of wild type (*1/*1), or *28, *6 genetic polymorphism single hetero-type (*1/*28, *1/*6).
9) The RAS mutation status (wild-type, mutant or not definable) of the patients is known prior to randomization.
Key exclusion criteria
1) Serious complications.
2) Receipt of a blood transfusion or hematopoietic factor therapy within 2 weeks prior to registration.
3) Grade >=2 peripheral sensory neuropathy.
4) History of Grade >=3 thromboembolism within 6 months before the scheduled treatment start date.
5) Receiving anti-platelet agents. Aspirin use at doses up to 325 mg/day is permitted.
6) Women who are pregnant, breastfeeding, had a positive pregnancy test, or women and men who do not wish to use contraception.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Kito |
Organization
Ishikawa Prefectural Central Hospital
Division name
Department of Medical Oncology
Zip code
920-8530
Address
2-1 Kuratsukihigashi, Kanazawa,Ishikawa 920-8530 , Japan
TEL
076-237-8211
kitoyo9100@gmail.com
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Ishizuka |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
556-0016
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Eli Lilly Japan K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Shizuoka Cancer Center Ethical Review Board for Clinical Studie
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan
Tel
055-989-5222
rinsho_office@scchr.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
| 2017 | Year | 03 | Month | 24 | 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 | 03 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 01 | 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 | 03 | Month | 13 | Day |
Last modified on
| 2024 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030459
