UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003979 |
|---|---|
| Receipt number | R000004795 |
| Scientific Title | A pilot study of efficacy and safety of aprepitant with chemoradiotherapy involving weekly cisplatin in patients with cervical cancer. |
| Date of disclosure of the study information | 2010/08/06 |
| Last modified on | 2018/02/06 09:20:50 |
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Basic information
Public title
A pilot study of efficacy and safety of aprepitant with chemoradiotherapy involving weekly cisplatin in patients with cervical cancer.
Acronym
A pilot study of aprepitant with CCRT
Scientific Title
A pilot study of efficacy and safety of aprepitant with chemoradiotherapy involving weekly cisplatin in patients with cervical cancer.
Scientific Title:Acronym
A pilot study of aprepitant with CCRT
Region
| Japan |
Condition
Condition
cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the efficacy and safety of aprepitant with chemoradiotherapy involving weekly cisplatin in patients with cervical cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The proportion of nausea, vomiting, fatigue and headache as graded by CTCAE v.4.0 with or without aprepitant.
Key secondary outcomes
1. the evaluation of QOL using FLIE.
2. the proportion of patients who completed more than 5 courses.
3. comparison of 6B-OHF in urine.
4. adverse events.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
aprepitant
Interventions/Control_2
observation
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
Female
Key inclusion criteria
1. patients with chemoradiotherapy containinig weekly cisplatin in FIGO stage IB2, II, III, IVA cervical cancer.
2. cisplatin: 40mg/m2/week.
3. Performance Status: 0-2
4. Adequate organ functions.
5. patients who can mention a diary.
6. patients who have signed to an approved informed consent.
Key exclusion criteria
1. patients with received pimozide.
2. patients with history of chemotherapy with cisplatin.
3. patients with vomiting within 24 hours before first administrating of cisplatin.
4. patients who have had any other cancer.
5. patients who are pregnant or breast feeding.
6. patients with severe complications (heart disease, uncontrolled diabetes,bleeding tendency).
7. patients with active infection disease whom steroid is inappropriate for.
8. patients who have a history of hypersensitivity to drugs.
9. patients who were administered drugs in the following, 5-HT3 blocker, phenothiazine, butyrophenone, benzamide, dopamine receptor antagonist.
10. patients who are considered to be inappropriate for this study judged by the treating physician.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoto Furukawa |
Organization
Nara Medical University
Division name
Department of Obstetrics and Gynecology
Zip code
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
furunao@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoto Furukawa |
Organization
Nara Medical University
Division name
Department of Obstetrics and Gynecology
Zip code
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
Homepage URL
furunao@hotmail.com
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University
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
奈良県立医科大学
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 05 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 02 | Day |
Last modified on
| 2018 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004795
