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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN C000000406
Receipt No. R000000494
Scientific Title Clinical effects of azasetoron / dexamethasone combination-therapy on the prevention of nausea and vomiting caused by chemotherapy treatment for colon cancer patients - Comparative cross-over trial between azasetoron single-therapy and azasetoron/dexamethasone combination-therapy -
Date of disclosure of the study information 2006/04/17
Last modified on 2006/04/14

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Basic information
Public title Clinical effects of azasetoron / dexamethasone combination-therapy on the prevention of nausea and vomiting caused by chemotherapy treatment for colon cancer patients
- Comparative cross-over trial between azasetoron single-therapy and azasetoron/dexamethasone combination-therapy -
Acronym Comparative cross-over trial between azasetoron single-therapy and azasetoron/dexamethasone combination-therapy
Scientific Title Clinical effects of azasetoron / dexamethasone combination-therapy on the prevention of nausea and vomiting caused by chemotherapy treatment for colon cancer patients
- Comparative cross-over trial between azasetoron single-therapy and azasetoron/dexamethasone combination-therapy -
Scientific Title:Acronym Comparative cross-over trial between azasetoron single-therapy and azasetoron/dexamethasone combination-therapy
Region
Japan

Condition
Condition colon cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare antiemetic prophylactic effects and safety through the randomized cross-over trial between azasetoron single-therapy and azasetron/dexamethasone combination-therapy for colon cancer patients treated with chemotherapeutic agents such as Irinotecan, Oxaliplatin, Levofolinate and 5-FU
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes inhibition rate of vomiting events
Key secondary outcomes vomiting frequency, score of nausea, patient's feelings (anti-emesis, appetite)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 drip-infusion of azasetoron (10mg/body) before the administration of anti-cancer agents (day1)
Interventions/Control_2 drip-infusion of azasetoron (10mg/body) and dexamethason (8mg/body) before the administration of anti-cancer agents (day1)
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
80 years-old >
Gender Male and Female
Key inclusion criteria Colon cancer patients to be administered with chemotherapeutic agents such as Irinotecan, Oxaliplatin, Levofolinate or 5-FU (underlying disease: colon cancer)
Patients who have the abilities to agree with this study by themselves, or whose acceptance to this study can be obtained from their proxies in writing
Key exclusion criteria Patients to receive surgical treatment or irradiation treatment during the term of this study
Patients who develop complications of severe cardiovascular disease, hemodyscrasia, renal disease or hepatic disease.
Pregnant or lactating women
Patients with a history of hypersensitivity to any of the drugs used in this study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasushi Ichikawa
Organization Yokohama City University Graduate School of Medicine
Division name Department of Gastroenterological Surgery
Zip code
Address 3-9 Fukuura, Kanazawa-Ku, Yokohama
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Yokohama City University Graduate School of Medicine
Division name Department of Gastroenterological Surgery
Zip code
Address
TEL 045-787-2650
Homepage URL
Email

Sponsor
Institute Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Yokohama City University Graduate School of Medicine
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
2006 Year 04 Month 17 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 Preinitiation
Date of protocol fixation
2006 Year 01 Month 31 Day
Date of IRB
Anticipated trial start date
2006 Year 04 Month 01 Day
Last follow-up date
2008 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2006 Year 04 Month 14 Day
Last modified on
2006 Year 04 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000494

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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