Unique ID issued by UMIN | UMIN000007491 |
---|---|
Receipt number | R000008827 |
Scientific Title | Clinical evaluation of two antiemetic combinations palonosetron dexamethazone in paclitaxel and carboplatin: a randomized phase II trial. |
Date of disclosure of the study information | 2012/04/01 |
Last modified on | 2014/01/07 17:20:33 |
Clinical evaluation of two antiemetic combinations palonosetron dexamethazone in paclitaxel and carboplatin: a randomized phase II trial.
PALODEX
Clinical evaluation of two antiemetic combinations palonosetron dexamethazone in paclitaxel and carboplatin: a randomized phase II trial.
PALODEX
Japan |
patients with gynecological malignancies who are receiving paclitaxel/carboplatin.
Obstetrics and Gynecology |
Malignancy
NO
We evaluate the efficacy and tolerability of palonpsetron in combination with 1-day dexamethasone versus 3-day dexamethazone in patients with gynecologiccal malignancies who are receiving paclitaxel and carboplatin.
Efficacy
Exploratory
Pragmatic
Phase II
The primary endpoint is complete response(
no emetic episodes and no rescue medication) in delayed chemotherapy-induced nausea and vomiting.
The secondary endpoints are complete response in acute and overall chemotherapy-induced nausea and vomiting, and complete cntrol( no emetic episodes, no use of rescue medication, and no nausea), grade of nausea, and incidence of side effects in acute, delayed and overall chemotherapy-induced nausea and vomiting.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Dose comparison
NO
NO
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Medicine |
day1 palonosetron0.75mg plus dexamethazone20mg
day2,3 dexametazone8mg
day1 palonosetron0.75mg plus dexamethazone20mg
20 | years-old | <= |
Not applicable |
Female
1.Gynecological malignacies confirmed by histology.
2.No previous history of receiving chemotherapy.
3.Receiving paclitaxel175mg/m2 plus carboplatin AUC=5.
4.Adequate bone marrow,liver,and renal functions.
5.Performance Status 0-1
6.written informed consent
1.Serious complication as followings; interstitial pneumonia; pulmonary fibrosis; heartfailure; renal failure; hepatic failure; uncontrolled diabetes mellitus etc.
2.Patients with symptomatic brain metastasis.
3.Receiving antiseizure medications.
4.Severe ascites and / or pleural effusion.
5.Bowel obstruction.
6.Symptom of emesis.
7.Hypersensitivity to have a history palonosetron and / or other 5-HT3 receptor antagonists.
8.Hypersensitivity to have a history dexamethazone.
9.Pregnancy or lactation.
10.Previous history of receiving palonosetron.
11.Inappropriate patients for this study judged by the physicians
80
1st name | |
Middle name | |
Last name | Naoto Furukawa |
Nara Medical University
Department of Obstetrics and Gynecology
840 Shijo-cho, Kashihara
0744-22-3051
1st name | |
Middle name | |
Last name | Naoto Furukawa |
Nara Medical University
Department of Obstetrics and Gynecology
840 Shijo-cho, Kashihara
0744-22-3051
furunao0813@gmail.com
Nara Medical University
none
Other
NO
2012 | Year | 04 | Month | 01 | Day |
Unpublished
Completed
2012 | Year | 02 | Month | 28 | Day |
2012 | Year | 04 | Month | 01 | Day |
2014 | Year | 01 | Month | 07 | Day |
2014 | Year | 01 | Month | 07 | Day |
2014 | Year | 01 | Month | 07 | Day |
2014 | Year | 01 | Month | 07 | Day |
2012 | Year | 03 | Month | 13 | Day |
2014 | Year | 01 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008827