UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052322 |
|---|---|
| Receipt number | R000059731 |
| Scientific Title | A multicenter, prospective, observational study for the control of delayed chemotherapy-induced nausea and vomiting for upper gastrointestinal cancer |
| Date of disclosure of the study information | 2023/09/27 |
| Last modified on | 2025/03/29 22:52:23 |
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Basic information
Public title
A multicenter, prospective, observational study for the control of delayed chemotherapy-induced nausea and vomiting for upper gastrointestinal cancer
Acronym
A multicenter, prospective, observational study for the control of delayed chemotherapy-induced nausea and vomiting for upper gastrointestinal cancer
Scientific Title
A multicenter, prospective, observational study for the control of delayed chemotherapy-induced nausea and vomiting for upper gastrointestinal cancer
Scientific Title:Acronym
A multicenter, prospective, observational study for the control of delayed chemotherapy-induced nausea and vomiting for upper gastrointestinal cancer
Region
| Japan |
Condition
Condition
Upper gastrointestinal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to collect information on nausea and vomiting during triple antiemetic therapy including Fosnetupitant in upper gastrointestinal cancer patients undergoing chemotherapy with high or moderate emetic risk.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete suppression rate of emesis within 168 hours from the start of treatment
Key secondary outcomes
Incidence of vomiting or nausea, degree of nausea, additional antiemetic measures, adverse events (according to Common Terminology Criteria for Adverse Events)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. Cases diagnosed with upper gastrointestinal cancer and scheduled for initial chemotherapy with HEC regimen containing Cisplatin
2. Cases diagnosed with upper gastrointestinal cancer and scheduled for initial chemotherapy with MEC regimen containing Oxaliplatin
3. Diagnosed with upper gastrointestinal cancer, chemotherapy containing HEC containing Cisplatin or MEC containing Oxaliplatin was performed, antiemetic therapy containing an NK1 receptor antagonist antiemetic other than fosnetupitant was performed, and in which vomiting cannot be controlled
4. Cases in which the physician has determined that evaluation of nausea and vomiting associated with chemotherapy is possible
5. Cases aged 20 years or older at the time of obtaining consent
6. Cases where triple-drug combination therapy (Fosnetupitant, Palonosetron, Dexamethasone) is planned
Key exclusion criteria
1. Cases in which emetic events are observed due to factors other than cancer chemotherapy (e.g., emetic events due to passage obstruction due to the underlying disease, emetic events due to brain metastases)
2. Cases receiving continuous systemic administration of steroids exceeding 10 mg/day of prednisone equivalent.
3. Cases in which the attending physician determines that enrollment in this study is inappropriate
4. Cases with a history of hypersensitivity to the components of Fosnetupitant, Palonosetron, and Dexamethasone
5. Pregnant women or women who may be pregnant
Target sample size
135
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Kodera |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2233
ykodera@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Koki |
| Middle name | |
| Last name | Nakanishi |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2249
Homepage URL
konakani@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya 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
Nagoya University
Address
65 Tsurumai-cho, Showa-ku, Nagoya
Tel
052-744-2061
ethics@med.nagoya-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
| 2023 | Year | 09 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter, prospective, observational study. Questionnaire regarding nausea and vomiting events
Management information
Registered date
| 2023 | Year | 09 | Month | 27 | Day |
Last modified on
| 2025 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059731
