UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005551 |
|---|---|
| Receipt number | R000006583 |
| Scientific Title | Preventive effect of combination therapy with aprepitant, palonosetron and dexamethasone on chemotherapy-induced nausea and vomiting (CINV) in esophageal cancer patients receiving 5-FU plus cisplatin: a prospective phase II study |
| Date of disclosure of the study information | 2011/06/01 |
| Last modified on | 2015/05/10 16:36:53 |
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Basic information
Public title
Preventive effect of combination therapy with aprepitant, palonosetron and dexamethasone on chemotherapy-induced nausea and vomiting (CINV) in esophageal cancer patients receiving 5-FU plus cisplatin: a prospective phase II study
Acronym
Preventive effect of combination therapy with aprepitant, palonosetron and dexamethasone on CINV in esophageal cancer patients receiving 5-FU plus cisplatin: a prospective phase II study
Scientific Title
Preventive effect of combination therapy with aprepitant, palonosetron and dexamethasone on chemotherapy-induced nausea and vomiting (CINV) in esophageal cancer patients receiving 5-FU plus cisplatin: a prospective phase II study
Scientific Title:Acronym
Preventive effect of combination therapy with aprepitant, palonosetron and dexamethasone on CINV in esophageal cancer patients receiving 5-FU plus cisplatin: a prospective phase II study
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of combination therapy with aprepitant, palonosetron and dexamethasone on CINV in esophageal cancer patients receiving 5-FU plus cisplatin.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The proportion of patients with a complete response (defined as no vomiting and no rescue medication) during the delayed phase after administration of 5-FU plus cisplatin
Key secondary outcomes
1. The proportion of patients with a complete response during the acute phase and overall phases after administration of 5-FU plus cisplatin
2. The proportion of patients with a complete control (defined as no vomiting, no rescue medication, and no more than mild nausea) during the acute phase, the delayed phase and overall phases
3. The degree of nausea during the acute phase, the delayed phase and overall phases
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
1. 5-FU plus cisplatin
Cisplatin is administered at a dose of 80 mg/m2 by slow drip infusion for 2h on day 1, and 5-FU is administered at a dose of 800 mg/m2 per day by continuous infusion for 24 h on days 1-5
2. Antiemetic drugs
1) Aprepitant is given at a dose of 125mg orally before the cisplatin administration on day 1, and 80mg orally on days 2-3
2) Palonosetron is given at a dose of 0.75mg intravenously before the cisplatin administration on day 1
3) Dexamethasone is given at a dose of 9.9mg intravenously before the cisplatin administration on day 1, and 6.6mg on days 2-5
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Histologically confirmed esophageal carcinoma
2. Patients who receive chemotherapy consists of 5-FU plus cisplatin
3. ECOG performance status of 0-2
4. Adequate organ function
5. Sufficient oral intake
6. Written informed consent
Key exclusion criteria
1. Severe complications (intestinal paralysis, symptomatic cardiovascular disease, pulmonary fibrosis, uncontrollable diabetes mellitus, active peptic ulcer, psychiatric disorder, cerebrovascular disorder)
2. Brain metastasis
3. Seizure disorder needing anticonvulsants
4. Massive ascites or pleural effusion
5. Intestinal obstruction
6. Vomiting, or grade 2 or higher nausea according to CTCAE ver4.0
7. QTc>470msec (examined within 28 days before registration)
8. Hypersensitivity or severe drug allergy to aprepitant, palonosetron or other 5-HT3-receptor antagonists
9. Hypersensitivity or severe drug allergy to dexamethasone
10. Pregnant or breast-feeding woman
11. Men of wishing fertility
12. Administration of pimozide
13. Not appropriate for the study at the physician's assessment
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ayumu Hosokawa |
Organization
University of Toyama
Division name
Department of Gastroenterology and Hematology, Faculty of Medicine
Zip code
Address
2630 Sugitani, Toyama, 930-0194, Japan
TEL
076-434-7301
ayhosoka@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayumu Hosokawa |
Organization
University of Toyama
Division name
Department of Gastroenterology and Hematology, Faculty of Medicine
Zip code
Address
2630 Sugitani, Toyama, 930-0194, Japan
TEL
076-434-7301
Homepage URL
ayhosoka@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 01 | 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
| 2011 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | 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
| 2011 | Year | 05 | Month | 03 | Day |
Last modified on
| 2015 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006583
