UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of second-generation 5-HT3-receptor antagonist; palonosetron for prevention of nausea and emesis in patients receiving chemotherapy including cisplatin for gastric cancer.
Title of the study (Brief title)	Effect of palonosetron in patient receiving chemotherapy including cisplatin for gastric cancer.
Region	Japan

Condition
Condition	Advanced gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy and safety of palonosetron for prevention of nausea and emesis in patients receiving chemotherapy involving cisplatin for gastric cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Ratio of complete response (defined as no emesis and no rescue treatment). [Time Frame: overall; 0-120hr after chemotherapy, acute phase; 0-24hr, delayed phase; 24-120hr].
Key secondary outcomes	1) ratio of patient without emesis. 2) ratio of patient without rescue treatment. 3) ratio of patient without nausea. 4) time to first emesis. 5) evaluation of volume of meal intake. 6) evaluation of QOL with Functional Living index-Emesis (FLIE) scale.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)patients receiving first course of chemotherapy containing cisplatin for gastric cancer. 2) aged 20 years or more. 3) patents had undergone treatment with high emetic risk and moderate emetic risk chemotherapy prior to this study 4) written informed consent from the patients.
Key exclusion criteria	1) patients with serious hepatic insufficiency or renal failure. 2) patients with emesis within 24 hours before first administrating of cisplatin. 3) patients who were administered antiemetic drugs within 48 hours before first administrating of cisplatin. 4) patients with emetic factor except for chemotherapy 5) patient who was intended radiation therapy 6) patients judged inappropriate for this study by physicians. 7) patients who received Pimozide.
Target sample size	75

Research contact person
Name of lead principal investigator	Sachio Fushida
Organization	Digestive Disease Support Organization (DDSO)
Division name	Gastroenterologic surgery
Address	35-1, Yonemaru-machi, Kanazawa, Ishikawa 921-8004, Japan
TEL	076-265-2000
Email	oya-ma@staff.kanazawa-u.ac.jp

Public contact
Name of contact person	Katsunobu Oyama
Organization	Digestive Disease Support Organization (DDSO)
Division name	Gastroenterologic surgery
Address	35-1, Yonemaru-machi, Kanazawa, Ishikawa 921-8004, Japan
TEL	076-265-2000
Homepage URL
Email	oya-ma@staff.kanazawa-u.ac.jp

Sponsor
Institute	Digestive Disease Support Organization (DDSO)
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Digestive Disease Support Organization (DDSO)
Organization
Division
Category of Funding Organization	Other
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	2012 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 09 Month 30 Day
Anticipated trial start date	2012 Year 10 Month 01 Day
Last follow-up date	2014 Year 07 Month 25 Day
Date of closure to data entry	2014 Year 07 Month 25 Day
Date trial data considered complete	2014 Year 07 Month 25 Day
Date analysis concluded	2015 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Complete response rate: 91.6% Complete protectionrate: 66.7%
Other related information	To investigate the efficacy and safety of palonosetron for prevention of nausea and emesis in patients receiving chemotherapy involving cisplatin for gastric cancer.

Management information
Registered date	2012 Year 10 Month 01 Day
Last modified on	2016 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/icdr_e/ctr_view.cgi?recptno=R000010581