UMIN-CTR Clinical Trial

Public title

A multicenter phase II trial of peri-operative chemotherapy with mFOLFOX6 for resectable liver metastases from colorectal cancer.

Acronym

A multicenter phase II trial of peri-operative chemotherapy with mFOLFOX6 for resectable liver metastases from colorectal cancer.

Scientific Title

A multicenter phase II trial of peri-operative chemotherapy with mFOLFOX6 for resectable liver metastases from colorectal cancer.

Scientific Title:Acronym

A multicenter phase II trial of peri-operative chemotherapy with mFOLFOX6 for resectable liver metastases from colorectal cancer.

Region

Japan

Condition

colorectal cancer

Classification by specialty

Gastrointestinal surgery

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and the safety of peri-operative chemotherapy for metastatic colorectal cancer with resectable liver metastases.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Liver resection rate

Key secondary outcomes

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

Pre-operative chemotherapy(mFOLFOX6) 4cycles followed by surgical hepatectomy followed by post-operative chemotherapy (mFOLFOX6) 8cycles, mFOLFOX6(L-OHP85mg/m2, Levofolinate200mg/m2, 5-FU/bolus400mg/m2, 5-FU/continuous2,400mg/m2
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

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. Patients with histologically proven colorectal cancer
2. With measurable lesions in the liver only (no extrahepatic disease)
3. Resectable synchronous and metachronous liver metastases
4. No prior chemotherapy for colorectal cancer
5. No prior radiotherapy for colorectal cancer
6. Performance status(ECOG):0, 1
7. Life expectancy of more than 3 months
8. Sufficient organ functions
9. Written informed consent

Key exclusion criteria

1. Serious drug hypersensitivity or a history of drug allergy
2. Peripheral neuropathy
3. Active concomitant malignancy
4. Severe infectious disease
5. Serious complications (renal failure or hepatic failure)
6. High blood pressure and diabetic and hypercalcemia that cannot be controlled
7. Symptomatic or asymptomatic but treated heart disease
8. Symptomatic or asymptomatic but treated heart disease
9. Histry of mental disturbances or cerebrovascular attack
10. Fresh hemorrhage from digestive tube, intestines tube paralysis, intestinal obstruction and peptic ulcer
11. Plerral effusion, peritoneal fluid and pericardial fluid
12. Symptomatic brain metastasis
13. Water solubility diarrhea, in case of the patient who has a colostomy, diarrhea impairs daily life activity
14. Under coutinuous steroid therapy
15. History of organ transplantation
16. Traumatic gracture of unrecovery
17. Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers
18. Other conditions not suitable for this study

Target sample size

40

Name of lead principal investigator

1st name	Akihiko
Middle name
Last name	Tuchida

Organization

Tokyo Medical University

Division name

department of gastrointestinal and pediatric surgery

Zip code

1600023

Address

6-7-1 Nish-Shinjyuku Shinjyuku Tokyo

TEL

0333426111

Email

k-katsu@tokyo-med.ac.jp

Name of contact person

1st name	Kenji
Middle name
Last name	Katsumata

Organization

Tokyo Medical University

Division name

department of gastrointestinal and pediatric surgery

Zip code

1600023

Address

6-7-1 Nish-Shinjyuku Shinjyuku Tokyo

TEL

0333426111

Homepage URL

Email

k-katsu@tokyo-med.ac.jp

Institute

3rd department of surgery
Tokyo Medical University

Institute

Department

Personal name

Organization

Tokyo Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Tokyo Medical University

Address

6-7-1 Nish-Shinjyuku Shinjyuku Tokyo

Tel

0333426111

Email

k-katsu@tokyo-med.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

東京医科大学病院（東京都）

Date of disclosure of the study information

2013

Year

01

Month

15

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

Open public recruiting

Date of protocol fixation

2012

Year

10

Month

02

Day

Date of IRB

Anticipated trial start date

2012

Year

11

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

2013

Year

01

Month

08

Day

Last modified on

2020

Year

07

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011399