UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief 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.
Region	Japan

Condition
Condition	Cervical cancer
Classification by specialty	Obsterics 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	Ikuo Konishi
Organization	Kyoto University Graduate School of Medicine
Division name	Gynecology and Obstetrics
Address	54 Shogoinkawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan
TEL	0757513269
Email	babatsu@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Masafumi Koshiyama
Organization	Kyoto University Graduate School of Medicine
Division name	Gynecology and Obstetrics
Address	54 Shogoinkawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan
TEL	0757513269
Homepage URL
Email	babatsu@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Graduate School of Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 01 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.medscimonit.com/download/index/idArt/899741
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005903