UMIN-CTR Clinical Trial

Public title

A phase I/II triral of S-1 plus L-OHP for colorectal cancer liver metastases after hepatic resection

Acronym

A phase I/II triral of S-1 plus L-OHP for colorectal cancer liver metastases after hepatic resection

Scientific Title

A phase I/II triral of S-1 plus L-OHP for colorectal cancer liver metastases after hepatic resection

Scientific Title:Acronym

A phase I/II triral of S-1 plus L-OHP for colorectal cancer liver metastases after hepatic resection

Region

Japan

Condition

colorectal liver metastases

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To clarify the efficacy

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

3-year disease free survival

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

S-1, Oxaliplatin

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)liver metastasis is histologically diagnosed as colorectal cancer.
2)Curative resection is performed for primary tumors and liver metastasis
3)Primary liver resecion and recurrent liver resection
4)There are no distant metastasis, recurrences except the liver.
5)There is no history of thermocoagulation therapy and cryotherapy for livermetastasis.
6)The age is between 20 years old and 80years old at the registration day.
7)Performance status is 0-2 cases.
8)A major organ function is maintained by a laboratory study within 14 days before registration.
9)The oral intake of the drug is possible.
10)Treatment can start within eight weeks after an operation.
11)An agreement is obtained in a document from the patients

Key exclusion criteria

1)Surgical stump was clearly positive.
2)Case with the history of usage of S-1 or the L-OHP
3)Multiple primary cancer
4)Serious postoperative complications
5)Case with the following complications
-In insulin therapy or diabetes mellitus inadequate control
-Poor control hypertension (systolic blood pressure more than 180mmHg)
-Heart failure within six months, myocardial infarction, angina and remarkable electrocardiogram abnormal.
-Severe liver disease
-Severe renal disease
-Interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema
5)Active infection
6)Peripheral sensory nerve disorder
7)Peripheral sensory nerve disorder
8)Previous serious drug hypersensitivity
9)The case that uses flucytosine, phenytoin, warfarin potassium
10)A pregnant woman or the women who may be pregnant. Men in hope of the pregnancy of the partner.
11)The patients complicated with psychosis or neurologic manifestation, and judged to have difficulty in participation in clinical trials
12)The case judged to be unsuitable for registration

Target sample size

55

Name of lead principal investigator

1st name
Middle name
Last name	Norihiro Kokudo

Organization

Graduate School of Medicine, University of Tokyo

Division name

Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery

Zip code

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Graduate School of Medicine, University of Tokyo

Division name

Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery

Zip code

Address

TEL

Homepage URL

Email

Institute

Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery,
Graduate School of Medicine, University of Tokyo,

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

Date of disclosure of the study information

2011

Year

09

Month

23

Day

URL releasing protocol

Publication of results

Published

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

Completed

Date of protocol fixation

2011

Year

08

Month

03

Day

Date of IRB

Anticipated trial start date

2011

Year

09

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

2011

Year

09

Month

23

Day

Last modified on

2016

Year

12

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007573