UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010181 |
|---|---|
| Receipt number | 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 16:13:04 |
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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
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
Sponsor or person
Institute
Hitachi General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011923
