UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006310
Receipt number R000007461
Scientific Title Phase II study of early start of chemotherapy after excision of the primary colorectal cancer. (FUTURE 1102-Pearl star 02)
Date of disclosure of the study information 2011/09/20
Last modified on 2019/05/23 16:09:02

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Basic information

Public title

Phase II study of early start of chemotherapy after excision of the primary colorectal cancer. (FUTURE 1102-Pearl star 02)

Acronym

Phase II study of early start of chemotherapy after excision of the primary colorectal cancer. (FUTURE 1102-Pearl star 02)

Scientific Title

Phase II study of early start of chemotherapy after excision of the primary colorectal cancer. (FUTURE 1102-Pearl star 02)

Scientific Title:Acronym

Phase II study of early start of chemotherapy after excision of the primary colorectal cancer. (FUTURE 1102-Pearl star 02)

Region

Japan


Condition

Condition

Colorectal Cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of the early start of chemotherapy after excision of the primary colorectal cancer.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Efficacy

Key secondary outcomes

Response rate
Time to treatment failure
Overall survival
Progression free survival
Safety


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

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

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.Histologically confirmed colorectal cancer
2.Unresectable synchronous liver metastases
3.Resection of primary colorectal cancer
4.No prior chemotherapy and radiotherapy for colorectal cancer
5.Performance Status: 0-1 (ECOG criteria)
6.Age: 20 years to 75 years
7.Vital organ functions are preserved within 7 days prior to entry
WBC :>= 3,000 and =< 12,000/mm3
Neutrophil : >=1,500/mm3
Platelet : >= 100,000/mm3
T.bil.: <= 2.0 mg/dl
AST,ALT : <=100IU/l(in case of hepatic metastatic patients are <= 200IU/l)
Creatinin : <= 1.35mg/dl(female),1.80mg/dl(male)
8.Signed written informed consent

Key exclusion criteria

1.Prior severe drug allergy
2.Cavity fluid which needs drainage
3.Presence of active infection
4.Symptomatic brain metastases
5.Multiple malignancy within 5 years disease free interval
6.Uncontrolled hypertension
7.Uncontrolled diabetes
8.Peripheral nerve disorder
9.Severe pulmonary disease
10.Significant electrocardiographic abnormality
11.Treatment with anti-platelet drug
12.Chronic systemic treatment of corticosteroid
13.Nursing or pregnant females, or females or males with female partners who are planning to pregnancy
14.Inadequate for study enrollment by the physician

Target sample size

18


Research contact person

Name of lead principal investigator

1st name Yoichiro
Middle name
Last name Yoshida

Organization

Fukuoka University School of Medicine

Division name

Department of Gastroenterological Surgery

Zip code

814-0180

Address

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

TEL

0928011011

Email

yy4160@yahoo.co.jp


Public contact

Name of contact person

1st name Yoichiro
Middle name
Last name Yoshida

Organization

Fukuoka University School of Medicine

Division name

Gastroenterological Surgery

Zip code

814-0180

Address

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

TEL

0928011011

Homepage URL


Email

yy4160@yahoo.co.jp


Sponsor or person

Institute

Fukuoka Tumor Research(FUTURE)

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Fukuoka Univesity

Address

7-45-1,Nanakuma

Tel

0928011011

Email

yy4160@yahoo.co.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

福岡大学医学部消化器外科学


Other administrative information

Date of disclosure of the study information

2011 Year 09 Month 20 Day


Related information

URL releasing protocol

https://www.ncbi.nlm.nih.gov/pubmed/29863132

Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/29863132

Number of participants that the trial has enrolled

18

Results

https://www.ncbi.nlm.nih.gov/pubmed/29863132

Results date posted

2019 Year 05 Month 23 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Same as above

Participant flow

Same as above

Adverse events

Same as above

Outcome measures

Same as above

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2011 Year 06 Month 01 Day

Date of IRB

2011 Year 08 Month 21 Day

Anticipated trial start date

2011 Year 09 Month 01 Day

Last follow-up date

2015 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 09 Month 08 Day

Last modified on

2019 Year 05 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007461


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name