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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022440
Receipt No. R000025705
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)
Date of disclosure of the study information 2016/06/01
Last modified on 2016/07/12

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Basic information
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
Condition Colorectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
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

Assessment
Primary outcomes safety
Key secondary outcomes

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Osaka University Hospital
Institute
Department

Funding Source
Organization Self finding
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
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2016 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
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
Other related information

Management information
Registered date
2016 Year 05 Month 24 Day
Last modified on
2016 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025705

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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