UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010460 |
|---|---|
| Receipt number | R000012224 |
| Scientific 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. |
| Date of disclosure of the study information | 2013/04/10 |
| Last modified on | 2016/10/19 22:23:21 |
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Basic information
Public 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.
Acronym
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.
Scientific 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.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Kubota |
Organization
Yokohama city university graduate school of medicine
Division name
Department of urology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL
045-787-2679
nakaigan@med.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noboru Nakaigawa |
Organization
Yokohama city university graduate school of medicine
Division name
Department of urology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL
045-787-2679
Homepage URL
nakaigan@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama city university
Institute
Department
Personal name
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
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 |
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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012224
