UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II trial of combination therapy with palonosetron / dexamethasone or palonosetron / aprepitant / dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients with urothelial cancer.
Title of the study (Brief title)	A phase II trial of combination therapy with palonosetron / dexamethasone or palonosetron / aprepitant / dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients with urothelial cancer.
Region	Japan

Condition
Condition	urothelial cancer
Classification by specialty	Hematology and clinical oncology Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of combination therapy with palonosetron / dexamethasone (in moderately emetic CINV) or palonosetron / aprepitant / dexamethasone (in high emetic CINV) in patients with urothelial cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Complete response rate during 120 hours (all phase) after a platinum agent dosage start
Key secondary outcomes	1. Complete response rate during 0 to 24 hours (acute phase) and 24 to 120 hours (delay phase ) after a platinum agent dosage start 2. Complete control rate during acute phase and delay phase and all phase after a platinum agent dosage start 3. Grade of nausea during acute phase and delay phase and all phase after a platinum agent dosage start 4. Safety

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	Moderately emetic chemotherapy Palonosetron 0.75mg iv. prior to a platinum agent dosage start Dexamethasone 9.9mg iv. prior to a platinum agent dosage start 8mg po. day2-4 High emetic chemotherapy Palonosetron 0.75mg iv. prior to a platinum agent dosage start Dexamethasone 9.9mg iv. prior to a platinum agent dosage start 8mg po. day2-4 Aprepitant 125mg po. prior to a platinum agent dosage start 80mg po. day2, 3 or Fosaprepitant 150mg iv. prior to a platinum agent dosage start
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. The patient who plans the medication of the following anticancer agents as urothelial cancer chemotherapy Moderately emetic chemotherapy-GN therapy High emetic chemotherapy-MVAC or GC therapy 2. The patient whom an anticancer agent is not given to or an anticancer agent of low emetic risk has been given to in the past 3. Age at the time of the registration is a patient 20 years or older 4. Adequate organ function 5. ECOG performance status of 0 or 1 6. Given written informed consent
Key exclusion criteria	1. Receiving pimozide (MVAC or GC therapy) 2. With other sever diseases 3. Clinical suspicion or history of metastasis to brain or meninges 4. Patients who need anticonvulsants therapy 5. Ascites and/or pleural effusion to need treatment 6. Pyloric stenosis and/or intestinal obstruction 7. Vomiting, or grade 2 or higher nausea according to CTCAE ver4.0 8. History of drug allergy 9. Pregnant or lactating women or women of childbearing potential, and no birth-control 10. Patient who doesn't have ability or intention that cooperates for procedure of the study 11. Not appropriate for the study at the physician's assessment
Target sample size	80

Research contact person
Name of lead principal investigator	Yoshinobu Kubota
Organization	Yokohama city university graduate school of medicine
Division name	Department of urology
Address	3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL	045-787-2679
Email	nakaigan@med.yokohama-cu.ac.jp

Public contact
Name of contact person	Noboru Nakaigawa
Organization	Yokohama city university graduate school of medicine
Division name	Department of urology
Address	3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL	045-787-2679
Homepage URL
Email	nakaigan@med.yokohama-cu.ac.jp

Sponsor
Institute	Yokohama city university
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	大口東総合病院 小田原市民病院 神奈川県立足柄上病院 神奈川県立がんセンター 神奈川リハビリテーション病院 川崎市立井田病院 国際親善病院 国立病院機構相模原病院 済生会横浜市南部病院 茅ヶ崎市民病院 東芝林間病院 秦野赤十字病院 平塚共済病院 藤沢市民病院 藤沢湘南台病院 大和市立病院 横浜栄共済病院 横浜市立市民病院 横浜市立大学附属市民総合医療センター 横浜市立大学附属病院 横浜みなと赤十字病院 横浜南共済病院 横須賀共済病院

Other administrative information
Date of disclosure of the study information	2013 Year 04 Month 10 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 04 Month 01 Day
Anticipated trial start date	2013 Year 05 Month 01 Day
Last follow-up date
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	2013 Year 04 Month 10 Day
Last modified on	2016 Year 10 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012224