UMIN-CTR Clinical Trial

Public title

A randomized phase II study of XELOX plus Bevacizumab versus XELIRI plus Bevacizumab for advanced colorectal cancer with or without mitochondrial transcription factor A (mtTFA) expression.

Acronym

FUTURE1001 study

Scientific Title

A randomized phase II study of XELOX plus Bevacizumab versus XELIRI plus Bevacizumab for advanced colorectal cancer with or without mitochondrial transcription factor A (mtTFA) expression.

Scientific Title:Acronym

FUTURE1001 study

Region

Japan

Condition

Unresectable advanced/recurrent 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

Multicenter randomized phase II study of XELOX plus Bevacizumab versus XELIRI plus Bevacizumab for advanced/recurrent colorectal cancer with or without mtTFA expression.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Response rate with or without mtTFA expression

Key secondary outcomes

Progression free survival with or without mtTFA expression
Overall survival with or without mtTFA expression
Safety

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

mtTFA(+):Oxaliplatin 130mg/m2 i.v. (day1)
Bevaciumab 7.5mg/Kg i.v. (day1)
Capecitabine2,000mg/m2 p.o.(day1-14)
to be repeated every 3 weeks until progression

Interventions/Control_2

mtTFA(+):Irinotecan 200mg/m2 i.v. (day1)
Bevaciumab 7.5mg/Kg i.v. (day1)
Capecitabine1,600mg/m2 p.o.(day1-14)
to be repeated every 3 weeks until progression

Interventions/Control_3

mtTFA(-):Oxaliplatin 130mg/m2 i.v. (day1)
Bevaciumab 7.5mg/Kg i.v. (day1)
Capecitabine2,000mg/m2 p.o.(day1-14)
to be repeated every 3 weeks until progression

Interventions/Control_4

mtTFA(-):Irinotecan 200mg/m2 i.v. (day1)
Bevaciumab 7.5mg/Kg i.v. (day1)
Capecitabine1,600mg/m2 p.o.(day1-14)
to be repeated every 3 weeks until progression

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

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

1)Written informed consent.
2)Histologically confirmed adenocarcinoma of the colon or rectum.
3)unresectable or recurrent colorectal cancer.
4)No prior chemotherapy for the patients with unresectable or recurrent
colorectal cancer.
(1)Not include Neoadjuvant chemotherapy. (2)Previous adjuvant therapy is permitted if completed at least 6 months before registration.
5)No prior radiotherapy for target lesion.
6)Age >= 20 and =< 80.
7)Performance status(PS) of 0-2 in ECOG criteria.
8)With measurable lesion.
9)At least one measurable lesion based on the RECIST criterion. (within 28 days before registration)
10)Life expectancy more than 3 months.
11)Required baseline laboratory parameters (within 1 week before registration):
(1)WBC more than 2000 and WBC less than 12000/mm3.
(2)Neu more than 1,500/ mm3.
(3)Plt more than 75,000/ mm3.
(4)Hb more than 9.0g/dl.
(5)T-Bil less than 2.0mg/dl.
(6)AST,ALT 100IU/L and under.(<200 U/L in patients with liver metastasis)
(7)PT(INR) less than 1.5.
(8)Cre male:less than 1.35mg/dl, Female:less than 1.8mg/dl.
12)Urine protein controllable.

Key exclusion criteria

1)Administering transfusion/ hematopoietic factor or G-CSF and antithrombotic drug within 7 days.
2)Serious liver and renal dysfunction.
3)Serious drug hypersensitivity or a history of drug allergy.
4)Peripheral neuropathy.
5)Active double cancer.
6)Severe infectious disease.
7)High blood pressure and diabetic that cannot be controlled.
8)Symptomatic or asymptomatic but treated heart disease.
9)History of interstitial pneumonitis, pulmonary fibrosis or high-grade pulmonary emphysema.
10)History of mental disturbances or cerebrovascular accident.
11)Fresh hemorrhage from digestive tube, intestines tube paralysis, intestinal obstruction and peptic ulcer.
12)Current or previous (within one year) history of GI perforation.
13)Pleural effusion, peritoneal fluid and pericardial fluid.
14)Symptomatic brain metastasis.
15)Water solubility diarrhea.
16)Under coutinuous steroid therapy.
17)Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week.
18)Anti-platelets therapy.(including aspirin and NSAIDS)
19)History of organ transplantation.
20)Traumatic fracture of unrecovery.
21)Bevacizumab used previous chemotherapy.
22)Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers.
23)Other conditions not suitable for this study.

Target sample size

100

Name of lead principal investigator

1st name	Yoichiro
Middle name
Last name	Yoshida

Organization

Fukuoka University School of Medicine

Division name

Department of Gastroenterologial Surgery

Zip code

8140180

Address

7-45-1, Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan

TEL

+81928011011

Email

yyoshida@fukuoka-u.ac.jp

Name of contact person

1st name	Yoichiro
Middle name
Last name	Yoshida

Organization

Fukuoka University School of Medicine

Division name

Department of Gastroenterologial Surgery

Zip code

8140180

Address

7-45-1, Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan

TEL

09086695801

Homepage URL

Email

yyoshida@fukuoka-u.ac.jp

Institute

Fukuoka University Hospital

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Fukuoka University

Address

7-45-1Nanakuma, Jonanku

Tel

+81928011011

Email

yyoshida@fukuoka-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

福岡大学医学部　消化器外科学

Date of disclosure of the study information

2011

Year

02

Month

14

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

Terminated

Date of protocol fixation

2010

Year

12

Month

15

Day

Date of IRB

2011

Year

01

Month

15

Day

Anticipated trial start date

2011

Year

02

Month

01

Day

Last follow-up date

2013

Year

10

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

02

Month

09

Day

Last modified on

2023

Year

09

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006009