UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004962 |
|---|---|
| Receipt number | R000005903 |
| Scientific Title | Study of efficacy and tolerability of combination therapy with palonosetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients with cervical cancer. |
| Date of disclosure of the study information | 2011/02/01 |
| Last modified on | 2018/08/11 06:37:54 |
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Basic information
Public title
Study of efficacy and tolerability of combination therapy with palonosetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients with cervical cancer.
Acronym
Study of efficacy and tolerability of combination therapy with palonosetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients with cervical cancer.
Scientific Title
Study of efficacy and tolerability of combination therapy with palonosetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients with cervical cancer.
Scientific Title:Acronym
Study of efficacy and tolerability of combination therapy with palonosetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients with cervical cancer.
Region
| Japan |
Condition
Condition
Cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the efficacy and tolerability of a combination therapy with palonosetron and dexamethasone in patients receiving the chemotherapy with nedaplatin and irinotecan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The proportion of patients with complete response (CR: no vomiting and no use of rescue therapy ) in the delayed phase (24-120 hour after administration of nedaplatin and irinotecan)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
palonosetron 0.75mg (day 1) (iv)
Interventions/Control_2
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
# 20 Years and older
# Cervical cancer
# Patients with received the combination therapy with nedaplatin and irinotecan
# Adequate organ function for enrollment
# Performance Status : 0-2
# Patients with written informed consent
Key exclusion criteria
# They had serious complication.
(intestinal paralysis, lung fibrosis, diabetes mellitus, heart failure, myocardial infarction, angina pectoris, renal failure, psychiatric disorder, cerebrovascular accident, active gastric ulcer, active duodenal ulcer)
# No known CNS metastasis
# Patients who has a convulsive disorders that need anticonvulsants therapy
# They had ascites or pleural effusion needs paracentesis treatment
# Patients with obstruction of gastrointestinal tract,for example gastric outlet or ileus
# Patients with vomiting or nausea (>= Grade2)
# Hypersensitivity or severe drug allergy for Aloxi or other 5-HT3RA
# Hypersensitivity or severe drug allergy for dexamethasone
# Pregnant, breastfeeding or expecting woman
# Patients judged inappropriate for this study by physicians
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikuo Konishi |
Organization
Kyoto University Graduate School of Medicine
Division name
Gynecology and Obstetrics
Zip code
Address
54 Shogoinkawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan
TEL
0757513269
babatsu@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masafumi Koshiyama |
Organization
Kyoto University Graduate School of Medicine
Division name
Gynecology and Obstetrics
Zip code
Address
54 Shogoinkawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan
TEL
0757513269
Homepage URL
babatsu@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
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
| 2011 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.medscimonit.com/download/index/idArt/899741
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
Completed
Date of protocol fixation
| 2011 | Year | 01 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | 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
| 2011 | Year | 01 | Month | 26 | Day |
Last modified on
| 2018 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005903
