UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008552 |
|---|---|
| Receipt number | R000009961 |
| Scientific Title | A single-blind randomized controlled trial comparing Aprepitant plus (Granisetron)1st 5-HT3 receptor antagonist and Palonosetron for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapies including CBDCA in the gynecology cancer patients. |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2021/08/03 17:37:40 |
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Basic information
Public title
A single-blind randomized controlled trial comparing Aprepitant plus (Granisetron)1st 5-HT3 receptor antagonist and Palonosetron for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapies including CBDCA in the gynecology cancer patients.
Acronym
A single-blind randomized controlled trial for the prevention of
chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapies in the gynecology cancer patients.
Scientific Title
A single-blind randomized controlled trial comparing Aprepitant plus (Granisetron)1st 5-HT3 receptor antagonist and Palonosetron for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapies including CBDCA in the gynecology cancer patients.
Scientific Title:Acronym
A single-blind randomized controlled trial for the prevention of
chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapies in the gynecology cancer patients.
Region
| Japan |
Condition
Condition
Patients with gynecologic cancer receiving chemotherapy including carboplatin (that is, TC therapy: carboplatin + paclitaxel)
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect of antiemetic therapy with palonosetron and dexamethasone with that of triple antiemetic therapy with a 5-HT3 receptor antagonist, dexamethasone and a NK1 receptor antagonist (fosaprepitant) for prevention of nausea and vomiting caused by chemotherapy including carboplatin in patients with gynecologic cancer, with the goal of finding improved antiemetic treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint was the percentage of patients with a complete response (no vomiting and no salvage treatment) throughout the first course of chemotherapy.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Antiemetic therapy with palonosetron and dexamethasone
Interventions/Control_2
Triple antiemetic therapy with a 5-HT3 receptor antagonist, dexamethasone and a NK1 receptor antagonist (fosaprepitant)
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
Female
Key inclusion criteria
1. Patients with gynecologic cancer
undergoing chemotherapy including
carboplatin (>AUC 5) for the first
time.
2. Patients in whom the regimen used in
the first chemotherapy course is also
planned for the second and later
courses.
3. Patients who gave written consent to
participation in the study.
Key exclusion criteria
1. Patients complicated with serious
hepatic disorders or renal disorders.
2. Patients with nausea and vomiting
within 24 hours before initiation of
cancer chemotherapy.
3. Patients who used an antiemetic agent
within 48 hours before initiation of
cancer treatment.
4. Patients with nausea and vomiting due
to causes (brain tumor, digestive
passage disorders, active peptic
ulcer, brain metastasis, use of
opioids, etc.) other than cancer
chemotherapy.
5. Patients with an associated disease,
including uncontrolled diabetes, that
prevents administration of
dexamethasone for three days.
6. Patients under medication with
pimozide.
7. Patients for whom abdominal
radiotherapy is planned.
8. Patients with a history of vomiting
in past chemotherapy.
9. Patients judged to be inappropriate
for the study by the physician in
charge.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Nao |
| Middle name | |
| Last name | Suzuki |
Organization
St. Mariannna University, School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
2168511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
044-977-8111
nao@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuru |
| Middle name | |
| Last name | Ohara |
Organization
St. Mariannna University, School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
2168511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
044-977-8111
Homepage URL
hffbd516@yahoo.co.jp
Sponsor or person
Institute
St. Mariannna University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
NPO Kanagawa Supportive Care Group in Gynecologic Cancer(KSCGC)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Obstetrics and Gynecology,Tokai University School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Mariannna University, School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
Tel
044-977-8111
sanpu@marianna-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
聖マリアンナ医科大学病院（神奈川県）
東海大学医学部付属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 27 | Day |
Last modified on
| 2021 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009961
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| Registered date | File name |
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| Registered date | File name |
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