UMIN-CTR Clinical Trial

Public title

A phase II trial of FOLFIRI combined with hyperthermia as second-line therapy of unresectable colon cancer with liver metastases

Acronym

Combination therapy of FOLFIRI and hyperthermia in unresectable colon cancer with liver metastases

Scientific Title

A phase II trial of FOLFIRI combined with hyperthermia as second-line therapy of unresectable colon cancer with liver metastases

Scientific Title:Acronym

Combination therapy of FOLFIRI and hyperthermia in unresectable colon cancer with liver metastases

Region

Japan

Condition

Colon cancer patients with liver metastases who had been treated by FOLFOX as first-line therapy

Classification by specialty

Medicine in general

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The purpose of this study is to evaluate clinical efficacy and safety of the combination of FOLFIRI and hyperthermia in colon cancer patients with liver metastases who had been treated by FOLFOX as first-line therapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Response rate

Key secondary outcomes

Time to treatment failure, Overall survival, Safety

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

Device,equipment

Interventions/Control_1

FOLFIRI plus hyperthermia

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

Eligible criteria in this study are as follows:
1.Histologically confirmed colorectal cancer.
2.Unresectable/reccurent colorectal cancer
3.With liver metastasis
4.With FOLFOX as first-line therapy treated more than 2 courses.
5.More than 2 weeks after the final administration of FOLFOX
6.PS is 0, 1 or 2
7.Over 20 years of age
8.More than 12 weeks of expected survival period
9.With measurable lesion in liver
10.Sufficient functions of main organ
a) WBC: >=3,000/mm3 and <12,000/mm3
b) Neutrophyl: >=1,500/ mm3
c) Platelet: >=100,000/ mm3
d) T-Bil.: 1.5 times of normal range in each institute
e) GOT, GPT: 2.5 times of normal range in each institute
f)sCreatinin: within normal range in each institute
11.Wrtten informed consent

Key exclusion criteria

1.Patients who has received blood transfusion, blood products, and medicine made of blood formation factor within seven days of registration.
2.Medical history of severe hypersensitivity.
3.Massive ascites, pleural or pericardial effusin that required drainage.
4.With active infection.
5.With brain metastasis
6.With active double cancer.
7.Presence of uncontrolled hypertension.
8.Presence of uncontrolled diabetes.
9.Presence of unstable angina, myocardial infarction within three months.
10.Active gastrtrointestinal bleeding.
11.With intestinal paralysis, intestinal obstruction.
12.With diarrhea.
13.Patients receiving Atazanabil.
14.Pregnant or nursing women, men or women who like be pregnant.
15.Inappropriate patients for this study judged by the physicians.

Target sample size

25

Name of lead principal investigator

1st name
Middle name
Last name	Toshikazu Yoshikawa

Organization

Graduate School of Medical Science, Kyoto Prefectural University of Medicine

Division name

Molecular Gastroenterology and Hepatology

Zip code

Address

Kawaramachi-Hirokoji, Kaigyo-ku, Kyoto, Japan

TEL

075-251-5519

Email

s-kokura@koto.kpu-m.ac.jp

Name of contact person

1st name
Middle name
Last name	Satoshi Kokura

Organization

Graduate School of Medical Science, Kyoto Prefectural University of Medicine

Division name

Molecular Gastroenterology and Hepatology

Zip code

Address

Kawaramachi-Hirokoji, Kaigyo-ku, Kyoto, Japan

TEL

0752515519

Homepage URL

Email

s-kokura@koto.kpu-m.ac.jp

Institute

Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine

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

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

京都府立医科大学附属病院

Date of disclosure of the study information

2009

Year

06

Month

01

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

2009

Year

04

Month

30

Day

Date of IRB

Anticipated trial start date

2009

Year

06

Month

01

Day

Last follow-up date

2012

Year

03

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

05

Month

22

Day

Last modified on

2015

Year

10

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002409