UMIN-CTR Clinical Trial

Public title

Clinical trials for the safety and efficacy of the combination of XELOX,the colorectal cancer radical resection adjuvant chemotherapy and of chronic hepatitis therapeutic agent 3 oxygelmillpropionic acid polymer.(Phase 1 test)

Acronym

Seroshion test (adjuvant chemotherapy)

Scientific Title

Clinical trials for the safety and efficacy of the combination of XELOX,the colorectal cancer radical resection adjuvant chemotherapy and of chronic hepatitis therapeutic agent 3 oxygelmillpropionic acid polymer.(Phase 1 test)

Scientific Title:Acronym

Seroshion test (adjuvant chemotherapy)

Region

Japan

Condition

Colorectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

the aim is to evaluate the safety of 3-oxygelmill propionic acid polymer in combination with the adjuvant chemotherapy,XELOX for the radical surgery patients in the colorectal cancer cases.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

safety

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The dose of Seroshion is 1 capsule (10mg) after each meal,three times a day.We start the Seroshion administration at the first day of the chemotherapy,and also continue to intake it ,if you don't continue the chemotherapy. The end of chemotherapy is the end of Seroshion.

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

1)Patients diagnosed histologically colorectal cancer.
2)Curative resection,R0 was performed.
3)Patients are diagnosed pathological Stage3 at the postoperative time.
4)20 years older.
5)PS is 0 or 1.
6)Patients who don't receive the treatment except surgery.
7)Oral ingestion is possible.
8)Major organ function is checked by the clinical examination within 14 days.
9) Patients who can receive the treatment within postoperative 8 weeks.
10)The written consent is obtained.

Key exclusion criteria

1) Patients who could not resect curatively.
2) Patients with active double cancer.
3) Patients with severe drug hypersensitivity, or with a history of drug allergy.
4) Patients with serious complications (heart failure, renal failure, liver failure, bleeding ulcer, watery diarrhea, intestinal paralysis, intestinal obstruction, severe diabetes).
5)Patients of cirrhosis with jaundice or of suspected cirrhosis of the liver.
6)Patients with the history of chronic hepatitis B and with the experience of Seroshion.
7)Patients with active infection.
8)Women with the possibility of pregnancy,during pregnancy,with the hope of pregnancy,or with breast-feeding.
9)Patients with mental severe disorder.
10)Other cases who doctor determines that patients are unsuitable for safely carrying out the present study.

Target sample size

5

Name of lead principal investigator

1st name
Middle name
Last name	Mizushima Tsunekazu

Organization

Osaka University,Graduate School of Medicine

Division name

Gastroenterological Surgery

Zip code

Address

2-2,Yamadaoka,Suita City, Osaka

TEL

0668793251

Email

tmizushima@gesurg.med.osaka-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Mizushima Tsunekazu

Organization

Osaka University,Graduate School of Medicine

Division name

Gastroenterological Surgery

Zip code

Address

2-2,Yamadaoka,Suita City, Osaka

TEL

0668793251

Homepage URL

Email

tmizushima@gesurg.med.osaka-u.ac.jp

Institute

Osaka University Hospital

Institute

Department

Personal name

Organization

Self finding

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

2016

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

Open public recruiting

Date of protocol fixation

2016

Year

05

Month

26

Day

Date of IRB

Anticipated trial start date

2016

Year

05

Month

26

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

05

Month

24

Day

Last modified on

2021

Year

05

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025705