UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013797 |
|---|---|
| Receipt number | R000015834 |
| Scientific Title | A Multicenter, Clinical Phase II study of FOLFOXIRI with Bevacizumab As First-line Therapy in Patients with Metastatic Colorectal Cancer. |
| Date of disclosure of the study information | 2014/04/24 |
| Last modified on | 2015/08/28 11:51:02 |
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Basic information
Public title
A Multicenter, Clinical Phase II study of FOLFOXIRI with Bevacizumab
As First-line Therapy in Patients with Metastatic Colorectal Cancer.
Acronym
Quadruplet treatment trove reveal outcome for Japanese Patient.
Scientific Title
A Multicenter, Clinical Phase II study of FOLFOXIRI with Bevacizumab
As First-line Therapy in Patients with Metastatic Colorectal Cancer.
Scientific Title:Acronym
Quadruplet treatment trove reveal outcome for Japanese Patient.
Region
| Japan |
Condition
Condition
Patients with metastatic colorectal cancer.
Classification by specialty
| Medicine in general | Gastroenterology | Hematology and clinical oncology |
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of the combination of FOLFOXIRI with Bevacizumab (BV) as a first-line therapy in patients with metastatic colorectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Progression-free survival (PFS) at 10 months; by investigator-reported measurements.
Key secondary outcomes
Response rate (RR) ; by investigator-reported measurements, by central review
PFS; by central review
Overall survival (OS)
Efficacy by RAS status ; RR,PFS,OS
Incidence of adverse events
Time to treatment-failure
Completion rate in Induction treatment
Relative Dose Intensity
Treatment duration
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
[Induction treatment:FOLFOXIRI+BV]
Administered for a maximum of 12 cycles.
BV: 5mg/kg (d.i.v.)
L-OHP: 85 mg/sq.m (d.i.v.)
CPT-11:165mg/sq.m (d.i.v.)
l-LV:200mg/sq.m (d.i.v.)
5FU:3,200mg/sq.m (c.i.v.)
Administered every 2 weeks.
[Maintenance treatment:5-FU/LV+BV]
BV:5mg/kg (d.i.v.)
l-LV:200mg/sq.m (d.i.v.)
5FU:3,200mg/sq.m (c.i.v.)
Administered every 2 weeks.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Written Informed consent.
2. Histopathologically proven diagnosis of colorectal cancer (adenocarcinoma) excluding vermiform appendix cancer and proctos cancer.
3. Not resectable metastatic colorectal cancer
4. Age at enrollment is >= 20 and <= 75 years
5. ECOG PS < 2 if age < 70 years, ECOG PS = 0 if age = 71-75 years
6. One or more measurable lesion in RECIST ver.1.1 criteria according to contrast enhanced CT chest / abdomen / pelvis diagnosis.
7. Not previously treated with chemotherapy.
(Previous adjuvant by fluoropyrimidine monotherapy is allowed if more than 24 weeks have elapsed between the end of adjuvant therapy and first relapse.)
8. Vital organ functions (listed below) are preserved within 2 weeks prior to entry. Data recorded nearest to the entry should be referred. Blood transfusion or erythropoiesis stimulating agents less than 2 weeks prior to the tests are not allowed.
Neu. >= 1,500/cubicmillimeter
Pt. >= 100,000/cubicmillimeter
Hb. >= 9.0 g/dL
T-bil. <= 2.0 mg/dL
AST and ALT,ALP <= upper limit of normal (ULN)*2.5 (<= ULN*5 in case of liver metastasis)
Serum creatinine <= upper limit of normal (ULN) *1.5
PT-INR < 1.5
Proteinuria <= 2+
9. UGT1A1 genotype tested. Categorized into Wild or single Hetero.
Key exclusion criteria
1. Previously treated with irradiation to bone marrow constituting 20% or more of irradiation field.
2. Untreated brain metastases or spinal cord compression or primary brain tumors.
3. History of CNS disease.[except for asymptomatic Lacunar stroke]
4. Requiring chronic systemic corticosteroid treatment.
5. Current or recent ongoing treatment with anticoagulants.
6. Clinically significant cardiovascular disease for example cerebrovascular accidents, myocardial infarction, unstable angina, congestive heart failure, serious cardiac arrhythmia requiring medication.
7. Treatment with any investigational drug within 4 weeks.
8. Patient with Uncontrolled hypertension, Uncontrolled diabetes, Uncontrolled diarrhea->=grade 1 peripheral neuropathy, Active peptic ulcer, Non-healing wound, Clinically important diseases.
9. Major surgical procedure within 28 days prior to study treatment start, open biopsy, or significant traumatic injury, or anticipation of the need for major surgical procedure.
10. Lack of physical integrity of the upper gastrointestinal tract.
11. Pregnant women, lactating woman , positive by pregnancy test , wishing to become pregnant, and Sexually active males.
12. Hepatitis B or hepatitis C . Evidence of HIV infection.
13. Previous Chemotherapy for other organs.
14. Other active co-existing malignancies.
15. History / Presence of thrombosis within 1 year requiring medication.
16. History / Presence of paralytic ileus, obstruction or gastrointestinal perforation.
17. Malignant coelomic fluid required drainage.
18. History of allergy to Chinese hamster ovary cell proteins, or any of the components of the study medications.
19. History of fluoropyrimidine severe side effects caused by DPD defect.
20. Interstitial pneumonitis or pulmonary fibrosis.
21. Evidence or requiring systemic treatment for Infectious disease.
22. Patient who is judged by the investigator to be inappropriate for study participation for any reason.
Target sample size
65
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Kato,Akiyoshi Kanazawa |
Organization
Kansai Rosai Hospital,Kitano Hospital
Division name
Department of colorectal surgery,Department of Gastroenterological Surgery and Oncology
Zip code
Address
3-1-69 Inabaso, Amagasaki, Hyogo , Japan 660-8511, 2-4-20 Ohgamachi, Kita-ku, Osaka, Japan 530-8480
TEL
06-6416-1221
prj-quattro@eps.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Furuya |
Organization
EPS Corporation.
Division name
Clinical Information Division Data Manegement 1
Zip code
Address
6-29 Shinogawamachi,Shinjuku,Tokyo,162-0814,Japan
TEL
03-5684-7852
Homepage URL
prj-quattro@eps.co.jp
Sponsor or person
Institute
EPS Corporation
Institute
Department
Personal name
Funding Source
Organization
CHUGAI PHARMACEUTICAL 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
関西労災病院(兵庫県)
田附興風会医学研究所 北野病院(大阪府)
福岡県済生会福岡総合病院(福岡県)
愛知県がんセンター中央病院(愛知県)
神戸市立医療センター中央市民病院(兵庫県)
九州大学(福岡県)
国立がん研究センター東病院(千葉県)
静岡県立静岡がんセンター(静岡県)
熊本大学(熊本県)
福井県済生会病院(福井県)
名古屋大学(愛知県)
札幌医科大学(北海道)
中頭病院(沖縄県)
岐阜大学(岐阜県)
関西医科大学附属枚方病院(大阪府)
中通総合病院(秋田県)
京都府立医科大学(京都府)
国家公務員共済組合連合会 虎の門病院(東京都)
がん・感染症センター都立駒込病院(東京都)
北里大学(神奈川県)
薫風会 佐野病院(兵庫県)
慈泉会 相澤病院(長野県)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 03 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 23 | Day |
Last modified on
| 2015 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015834
