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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010181
Receipt No. R000011923
Scientific Title Optimal administration of fosaprepitant in patients with colon cancer
Date of disclosure of the study information 2013/03/06
Last modified on 2013/09/25

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Basic information
Public title Optimal administration of fosaprepitant in patients with colon cancer
Acronym Administration of fosaprepitant to colon cancer patients
Scientific Title Optimal administration of fosaprepitant in patients with colon cancer
Scientific Title:Acronym Administration of fosaprepitant to colon cancer patients
Region
Japan

Condition
Condition Colon Cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate adverse effects at the site of administration of fosaprepitant in patients with colon cancer and to find approaches to avoid these effects
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Pain at the injection site evaluated by NRS
Key secondary outcomes Development site, time of development, duration of symptoms, reaction of injection site, and procedures to decrease symptoms

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 1.5mg/mL
Interventions/Control_2 0.6mg/mL
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 with colon or rectal cancer
2) Age: 20 years old or older
3) Sex: Male or female
4) Patients with colon or rectal cancer undergoing chemotherapy including oxaliplatin or irinotecan* for the first time (naive patients) or those who have already received this therapy (non-naive patients)
5) Stage: Any stage, regardless of postoperative adjuvant chemotherapy or advanced or recurrent disease
6) Patients who give written informed consent to participate in the study
* CPT-11(weekly, biweekly), Erbitax+CPT-11, XELOX, XELOX+ Avastin, IRIS
Key exclusion criteria 1) Patients who previously developed serious or irreversible adverse effects at the administration site
2) Patients who were judged to be inappropriate as subjects by the study investigators
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name tsunehiko maruyama
Organization Hitachi General Hospital
Division name surgery
Zip code
Address 2-1-1,Jonann-cho,Hitachi-shi,Ibaraki-ken,317-0077Japan
TEL 0294-23-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name yuka aimono
Organization Hitachi General Hospital
Division name clinical reserch center
Zip code
Address 2-1-1,Jonann-cho,Hitachi-shi,Ibaraki-ken,317-0077Japan
TEL 0294-23-1111
Homepage URL
Email

Sponsor
Institute Hitachi General Hospital
Institute
Department

Funding Source
Organization None
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
2013 Year 03 Month 06 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 Terminated
Date of protocol fixation
2012 Year 12 Month 08 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 08 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
2013 Year 03 Month 06 Day
Last modified on
2013 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011923

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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