Unique ID issued by UMIN | UMIN000021593 |
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Receipt number | R000024901 |
Scientific Title | Exploratory study for prevention of nausea and vomiting switching from Granisetron + Dexamethasone (Day1-3) + Aprepitant (Day1-3) to Palonosetron + Dexamethasone (Day1) in patients given moderately emetogenic chemotherapy |
Date of disclosure of the study information | 2016/03/24 |
Last modified on | 2016/03/24 08:54:22 |
Exploratory study for prevention of nausea and vomiting switching from Granisetron + Dexamethasone (Day1-3) + Aprepitant (Day1-3) to Palonosetron + Dexamethasone (Day1) in patients given moderately emetogenic chemotherapy
Study for switching from GRA+DEX+APR to PALO+DEX
Exploratory study for prevention of nausea and vomiting switching from Granisetron + Dexamethasone (Day1-3) + Aprepitant (Day1-3) to Palonosetron + Dexamethasone (Day1) in patients given moderately emetogenic chemotherapy
Study for switching from GRA+DEX+APR to PALO+DEX
Japan |
colorectal cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
The aim of this study is to evaluate prevention of nausea and vomiting switching from Granisetron + Dexamethasone (Day1-3) + Aprepitant (Day1-3) to Palonosetron + Dexamethasone (Day1) in patients given L-OHP or CPT-11 containing chemotherapy, which correspond to the moderately emetogenic risk.
Safety
Exploratory
Phase II
Nausea (Overall study period)
Nausea (acute phase, delayed phase)
Complete Response (Overall study period, acute phase, delayed phase)
Complete Protection (Overall study period, acute phase, delayed phase)
Total Control (Overall study period, acute phase, delayed phase)
Evaluation method about nausea
Safety
Adverse event related to DEX
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
GRA+DEX (Day1-3)+APR(Day1-3)
PALO+DEX(Day1)
20 | years-old | <= |
85 | years-old | >= |
Male and Female
1) Age of 20 years or older
2) Histologically confirmed colorectal cancer
3) Chemotherapy including oxaliplatin or irinotecan is planned.
4) Chemotherapy 2 courses or more by the same regimen is expected
5) Adequate function of important organs
WBC >= 3000/mm3
AST < 100 IU/L
ALT < 100 IU/L
Ccr >= 60.0mL/min
6) Eastern Cooperative Oncology Group performance status (PS) 0-2
7) Written informed concent
1) Serious or uncontrolled complication (e.g. ileus or pulmonary fibrosis, diabetes, heart failure, myocardial infarction, angina, kidney failure, liver failure, mental disorder, cerebrovascular disease, active gastroduodenal ulcer)
2) Symptomatic or clinically suspected brain metastasis
3) Convulsive disorder needs anticonvulsants
4) Ascites fluid or pleural effusion needs paracentesis
5) Pyloristenosis or intestinal obstruction
6) Evident anticipatory nausea and vomiting
7) Hypersensitivity for components of 5-HT3 receptor antagonist, NK1 receptor antagonist, dexamethasone
8) Pregnancy, lactation or who does not wish to contraception
9) Capability or intention of cooperating
10) Undesirable for the patient to enter the trial
30
1st name | |
Middle name | |
Last name | Toshimoto Kimura |
Iwate Medical University, School of Medicine
Department of Surgery
Uchimaru 19-1, Morioka, Japan
019-651-5111
toshikim@iwate-med.ac.jp
1st name | |
Middle name | |
Last name | Toshimoto Kimura |
Iwate Medical University, School of Medicine
Department of Surgery
Uchimaru 19-1, Morioka, Japan
019-651-5111
toshikim@iwate-med.ac.jp
Iwate Medical University, School of Medicine
non
Self funding
NO
2016 | Year | 03 | Month | 24 | Day |
Unpublished
Open public recruiting
2016 | Year | 03 | Month | 20 | Day |
2016 | Year | 03 | Month | 25 | Day |
2016 | Year | 03 | Month | 24 | Day |
2016 | Year | 03 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024901
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