UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005623 |
|---|---|
| Receipt number | R000006635 |
| Scientific Title | Randomized study comparing the efficacy of aprepitant with palonosetron as antiemetic drug during chemotherapy including cisplatin |
| Date of disclosure of the study information | 2011/05/20 |
| Last modified on | 2020/10/30 21:43:49 |
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Basic information
Public title
Randomized study comparing the efficacy of aprepitant with palonosetron as antiemetic drug during chemotherapy including cisplatin
Acronym
KDOG 1002
Scientific Title
Randomized study comparing the efficacy of aprepitant with palonosetron as antiemetic drug during chemotherapy including cisplatin
Scientific Title:Acronym
KDOG 1002
Region
| Japan |
Condition
Condition
advanced or recurrent esophageal or gastric carcinoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of aprepitant versus palonosetron for chemotherapy-induced nausea and vomiting
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
complete response (no emesis and no rescue therapy) within 120 hours after the start of the first course of chemotherapy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
aprepitant
Interventions/Control_2
palonosetron
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patient with advanced or recurrent esophageal or gastric carcinoma
2. Chemotherapy including cisplatin 60 mg/m2 or more is planned
3. Chemotherapy-naive patient
4. Two courses or more of chemotherapy is planned
Key exclusion criteria
1. Serious heart disease, serious renal disease, serious liver disease, and poor controlled Diabetes
2. Woman during the pregnancy or with the possibility of the pregnancy
3. Patient with severe mental disorder
4. The allergic past history for the serotonin receptor antagonist
5. Patient with nausea, vomiting due to brain tumor or ileus
6. Patient who plans to receive radiotherapy for the chest, abdomen, or pelvis
7. Patient using antiemetic drug within 48 hours before chemotherapy
8.Patients who are judged inappropriate for the entry into this study by the investigator
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Wasaburo |
| Middle name | |
| Last name | Koizumi |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1, Kitazato, Sagamihara, Kanagawa, Japan
TEL
042-778-8111
k.ishido@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Ishido |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1, Kitazato, Sagamihara, Kanagawa, Japan
TEL
042-778-8111
Homepage URL
k.ishido@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kitasato University School of Medicine, Department of Gastroenterology
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
Kitasato University Medical Ethics Organization
Address
1-15-1 Kitasato, Minami-ku
Tel
+81427788111
rinrib@med.kitasato-u.ac.jp
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 | 05 | Month | 20 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/27254283/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/27254283/
Number of participants that the trial has enrolled
85
Results
The primary endpoint of complete response was not achieved, but AGD seems to be more effective than PD for the prevention of HEC-induced vomiting.
Results date posted
| 2020 | Year | 10 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
From November 2010 through August 2013, a total of 85 patients were enrolled in the study
Participant flow
One patient in the PD group suddenly died on day 5 of the first treatment cycle and was therefore excluded from the efficacy analysis. Effectiveness and safety were evaluated in the remaining 84 patients
Adverse events
none
Outcome measures
The complete response rate during the overall study period, the primary endpoint, was 67.4% in the AGD group and 58.5% in the PD group. This difference was not significant (p = 0.399).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2010 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 10 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 20 | Day |
Last modified on
| 2020 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006635
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