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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003979
Receipt No. 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

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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
Obsterics 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
Email 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
Email furunao@hotmail.com

Sponsor
Institute Nara Medical University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004795

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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