UMIN-CTR Clinical Trial

Public title

Phase II study of 5-FU dose-adjusted mFOLFOX7 plus Bevacizumab for patients with metastatic colorectal cancer(AJUST study)

Acronym

Phase II study of 5-FU dose-adjusted mFOLFOX7 plus Bmab (AJUST study)

Scientific Title

Phase II study of 5-FU dose-adjusted mFOLFOX7 plus Bevacizumab for patients with metastatic colorectal cancer(AJUST study)

Scientific Title:Acronym

Phase II study of 5-FU dose-adjusted mFOLFOX7 plus Bmab (AJUST study)

Region

Japan

Condition

Colorectal Cancer

Classification by specialty

Gastroenterology	Hematology and clinical oncology	Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluated the efficacy and toxicity of 5-FU dose-adjusted mFOLFOX7 plus Bmab.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Response Rate

Key secondary outcomes

1)Examination of 5-FU concentration in plasma
2)Relative dose intensity of oxaliplatin
3)Disease control rate
4)Time to treatment failure
5)Progression free survival
6)Overall survival
7)Resection rate
8)Adverse event

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

L-OHP 85mg/m^2 day1
Infusional 5-FU 2400mg/m^2 46hours
l-LV 200mg/m^2 day1
Bmab 5mg/kg day1
every 2 weeks

At first cycle, 5-FU concentrations are monitored. After second cycle, 5-FU are administered by the adjusted dose to mFOLFOX7+Bmab.

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histologically confirmed colorectal cancer.
2)No prior chemotherapy for metastatic disease.(Recurrence after 24 weeks of adjuvant therapy is registered)
3)With central venous infusion and infusion pump.
4)Measurable lesion based on RECIST
ver1.1.
5)PS(ECOG) 0-1.
6)Age of 20 years or older.
7)A life expectancy of more than 12 weeks.
8)No severe organ failure: and suitable results of all laboratory test performed within 14 days before enrollment.
---WBC >= 3,000/mm^3, <= 12,000/mm^3
---Neutrophil count >= 1,000/mm^3
---Plt >= 100,000/mm^3
---AST(GOT) and ALT(GPT) <= ULN x 2.5 (the patient has liver metastasis: <= ULN x 5)
---T-Bil <= ULN x 1.5
---Cr <= ULN x 1.5
---PT-INR <= 1.5
9) Written informed consent will be obtained from each patient before enrollment.

Key exclusion criteria

1)Blood transfusion or administration of blood products or hemopoietic factors within 7 days before enrollment.
2)A history of serious drug hypersensitivity.
3)Serious sensory abnormality or dysesthesia with associated dysfunction.
4)Surgery, biopsy specimen with section or sutures within the past 2 weeks.
5)Serious heart disease.
6)Bleeding, bleeding tendency, coagulopathy, coagulation factor abnormality
7)History of GI perforation within the past one year.
8)Metachronous double cancer within the past 5 years
9)Serious complication(intestinal obstruction, interstitial pneumonia, uncontrolled diabetes, peptic ulcer hypertension, renal failure, hepatic failure )
10)Uncontrolled effusion(peritoneal , pleural, cardiac effusion)
11)Brain metastasis
12)With infection or febrile patients.
13)Serious diarrhea.
14)Women who are pregnant, lactating, or wish to become pregnant.
15)Other conditions not suitable for this study.

Target sample size

45

Name of lead principal investigator

1st name
Middle name
Last name	Hideyuki Mishima

Organization

Aichi Medical University

Division name

Cancer Center

Zip code

Address

1-1 Yazakokarimata, Nagakute, Aichi

TEL

0561-63-0386

Email

hmishima@aichi-med-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Yumi Miyashita

Organization

Epidemiological and Clinical research Information Network (ECRIN)

Division name

ECRIN Data Center

Zip code

Address

1-7-9 Hanenishi, Okazaki, Aichi, JAPAN

TEL

0564-64-7330

Homepage URL

Email

miya@ecrin.or.jp

Institute

NPO Epidemiological and Clinical Research Information Network (ECRIN)

Institute

Department

Personal name

Organization

NPO Epidemiological and Clinical Research Information Network (ECRIN)

Organization

Division

Category of Funding Organization

Non profit foundation

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

Date of disclosure of the study information

2012

Year

02

Month

01

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Pharmacokinetic dose adjustment of 5-FU in modified FOLFOX7 plus bevacizumab for metastatic colorectal cancer in Japanese patients: a-JUST phase II clinical trial.

Denda T, Kanda M, Morita Y, Kim HM, Kashiwada T, Matsuda C, Fujieda S, Nakata K, Murotani K, Oba K, Sakamoto J, Mishima H.

Cancer Chemother Pharmacol. 2016 Nov 2. [Epub ahead of print]

RESULTS:

The median initial area under the concentration-time curve for FU was 23 mg h/L. Twenty-nine patients (60%) achieved the target concentration at the first cycle, and all 48 achieved it within the fourth cycle. The overall frequency of grade 3/4 adverse effects was 38%, with no significant difference between patients who did and not require dose adjustments. The overall response rate was 48% (95% confidence intervals = 34-62%). The median progression-free and overall survival rates were 11.3 and 24.1 months, respectively.

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

Completed

Date of protocol fixation

2011

Year

11

Month

30

Day

Date of IRB

Anticipated trial start date

2012

Year

01

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

02

Month

01

Day

Last modified on

2018

Year

09

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008240