UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of palonosetron and dexamethasone in patients who haven't responded to conventional antiemetic agents; granisetron and dexamethasone
Acronym	Efficacy and safety of palonosetron and dexamethasone in patients who haven't responded to conventional antiemetic agents; granisetron and dexamethasone
Scientific Title	Efficacy and safety of palonosetron and dexamethasone in patients who haven't responded to conventional antiemetic agents; granisetron and dexamethasone
Scientific Title:Acronym	Efficacy and safety of palonosetron and dexamethasone in patients who haven't responded to conventional antiemetic agents; granisetron and dexamethasone
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of palonosetron and dexamethasone in patients who haven't responded to conventional antiemetic agents; granisetron and dexamethasone.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Complete Response rate
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	Day 1 Palonosetoron 0.75mg/body and dexamethasone 12mg/body should be administered 30 minutes prior to chemotherapy Day 2-3 Dexamethasone 4mg/body should be administered orally.
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	Male and Female
Key inclusion criteria	1. Pathologically colorectal cancer 2. Age; more than 20 years-old at registration 3. Performance status of 0-2 4. Patients receiving moderate emetic chemotherapy including oxaliplatin or irinotecan 5. Patients who has vomited(including dry-vomiting) or been administered additional rescue 6. Adequate organ function 7. Written informed consent
Key exclusion criteria	1. Severe complication(s), e.g., congestive cardiac failure, coronary failure, cardiac infarction, angina pectoris, arrhythmia, cerebrovascular accident, active gastrointestinal tract ulcer, diabetes, renal failure, hepatic failure, active hepatitis or hepatic cirrhosis. 2. Symptomatic brain metastasis 3.Epilepsy patient treated with antiepileptic agent, exclusing being stable clinically 4.Combination radiotherapy 5. History of serious drug hypersensitivity for 5-HT3RA or dexamethasone. 6. History of administration of palonosetoron 7. Pregnant, nursing mothers or man who don't agree with contraception 8.Unsuitable patients judged by investigator
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuhiro Yoshida
Organization	Gifu University graduate school of medicine
Division name	Department of surgical oncology
Zip code
Address	1-1 Yanagido, Gifu city
TEL	058-230-6235
Email	kyoshida@gifu-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Takao Takahashi
Organization	Gifu University graduate school of medicine
Division name	Department of surgical oncology
Zip code
Address	1-1 Yanagido, Gifu city
TEL	058-230-6235
Homepage URL
Email	takaota@gifu-u.ac.jp

Sponsor
Institute	Gifu 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)

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

Other administrative information
Date of disclosure of the study information	2012 Year 12 Month 19 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	Completed
Date of protocol fixation	2012 Year 07 Month 04 Day
Date of IRB	2012 Year 07 Month 04 Day
Anticipated trial start date	2012 Year 07 Month 05 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry	2018 Year 03 Month 01 Day
Date trial data considered complete	2018 Year 03 Month 19 Day
Date analysis concluded	2018 Year 11 Month 03 Day

Other
Other related information

Management information
Registered date	2012 Year 12 Month 19 Day
Last modified on	2020 Year 06 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011247