UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized phase III trial of palonosetron versus palonosetron plus dexamethasone (day1) for the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy (HOPE-02)
Title of the study (Brief title)	A randomized phase III trial of PALO versus PALO plus DEX for the prevention of nausea and vomiting induced by MEC (HOPE-02)
Region	Japan

Condition
Condition	Colorectal Cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate non-inferiority of palonosetron to palonosetron plus dexamethasone (day1) in terms of complete response rate for moderately emetogenic chemotherapy (MEC) regimens.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase III

Assessment
Primary outcomes	Complete response rate (overall period)
Key secondary outcomes	Complete response rate (acute, delayed phase) Complete control rate (overall period, acute, delayed phase) Total control rate (overall period, acute, delayed phase) No rescue medication rate Antiemetic agents-related adverse events Influence of steroids long-term use *Change of antiemetic agents *Transition of HbA1c *Adverse events (allergic reaction, nausea, vomiting, anorexia)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Palonosetron 0.75mg/body Dexamethasone 9.9mg/body
Interventions/Control_2	Palonosetron 0.75mg/body
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.Age of 20 years or older 2.Diagnosis of malignancy 3.Prior chemotherapy with low or minimal emetogenicity, or no prior systemic chemotherapy 4.Moderately emetogenic chemotherapy is planned *Moderately emetogenic chemotherapy over 2 or more days is excluded * CDDP regimens are excluded regardless of its dosage *Also CBDCA regimens are excluded 5.Adequate bone marrow, liver and renal functions 6.ECOG performance status of 0-2 7.Written informed consent
Key exclusion criteria	1)Serious or uncontrolled complication 2)Symptomatic or clinically suspected brain metastasis 3)Convulsive disorder requiring anti-convulsant 4)Ascites fluid or pleural effusion requiring paracentesis 5)Gastrointestinal obstruction 6)Vomiting and/or grade 1 or more nausea at baseline 7)Patients with planned radiotherapy 8)History of hypersensitivity to 5-HT3 receptor antagonist 9)History of hypersensitivity to dexamethasone 10) Continuous administration of steroids 11) Poorly controlled nausea by opioids 12)Pregnancy, lactation or who does not wish to contraception 13)History of palonosetorn administration 14)Without capability or intention of cooperating with study procedure 15)Participant in other anti-emetic trial 16)Undesirable for the patient to enter the trial
Target sample size	320

Research contact person
Name of lead principal investigator	Yoshito Komatsu
Organization	Hokkaido University Hospital
Division name	Department of Cancer Chemotherapy
Address	North 14, West 5, Kita-Ku, Sapporo, Hokkaido, Japan
TEL	011-706-5657
Email	ykomatsu@med.hokudai.ac.jp

Public contact
Name of contact person	Satoshi Yuki
Organization	Hokkaido University Hospital
Division name	Department of Gastroenterology
Address	North 14, West 5, Kita-Ku, Sapporo, Hokkaido, Japan
TEL	011-706-5657
Homepage URL
Email	satoshi-yuuki175@joy.ocn.ne.jp

Sponsor
Institute	HOPE group(Hokkaido Supportive Care Oncology Project - an Expert Group Initiative)
Institute
Department

Funding Source
Organization	Hokkaido Gastrointestinal Cancer Study Group
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	北海道大学病院（北海道）他HOPE group参加施設

Other administrative information
Date of disclosure of the study information	2014 Year 02 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 28 Day
Anticipated trial start date	2014 Year 04 Month 01 Day
Last follow-up date	2017 Year 02 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 02 Month 24 Day
Last modified on	2017 Year 02 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015415