UMIN-CTR Clinical Trial

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

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

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

prj-quattro@eps.co.jp

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

Email

prj-quattro@eps.co.jp

Institute

EPS Corporation

Institute

Department

Personal name

Organization

CHUGAI PHARMACEUTICAL CO., LTD

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

Date of disclosure of the study information

2014

Year

04

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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