Unique ID issued by UMIN | UMIN000008897 |
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Receipt number | R000010437 |
Scientific Title | Randomized double-blind phase 3 study of granisetron vs palonosetron combined with dexamethasone plus fosaprepitant for patient with breast cancer treated with peri-operative AC/EC/FAC/FEC chemotherapy |
Date of disclosure of the study information | 2012/09/11 |
Last modified on | 2023/01/10 09:44:00 |
Randomized double-blind phase 3 study of granisetron vs palonosetron combined with dexamethasone plus fosaprepitant for patient with breast cancer treated with peri-operative AC/EC/FAC/FEC chemotherapy
Palonosetron vs granisetron as 3 drug combination to control emesis
Randomized double-blind phase 3 study of granisetron vs palonosetron combined with dexamethasone plus fosaprepitant for patient with breast cancer treated with peri-operative AC/EC/FAC/FEC chemotherapy
Palonosetron vs granisetron as 3 drug combination to control emesis
Japan |
Breast Cancer
Hematology and clinical oncology | Breast surgery |
Malignancy
NO
To investigate whether palonosetron outweighs granisetron, as prevention of emesis caused by peri-operatinve AC/EC/FAC/FEC chemotherapy in patients with breast cancer, combined with dexamethasone and fosaprepitant
Safety,Efficacy
Confirmatory
Phase III
Complete response rate for delayed emesis, defined as proportion of patients without vomiting nor rescue usage for emesis during 24 to 120 hours after chemotherapy
Complete response rate for emesis in acute (0 – 24 hours after chemotherapy) overall (0 to 120 hours after chemotherapy) phase, completer response rate for nausea or vomiting for acute/ delayed/ overall phase, safety
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
Central registration
2
Treatment
Medicine |
Granisetron
Palonosetron
20 | years-old | <= |
Not applicable |
Male and Female
1. Invasive breast cancer confirmed by histological diagnosis.
2. Eligible for peri-operatinve AC/ EC/ FAC/FEC chemotherapy and planning for it.
3. Age over 20 years old
4. ECOG PS as 0, 1, or 2
5. Adequate organ function defined as belows;
WBC >= 3000 mm^3
ANC >= 1500 mm^3
Hb >= 8 g/ dl
Plt >= 10 x 10^4/mm^3
AST, ALT <= 100 IU/ L
T-Bil <= 1.5 mg/ dl
sCr <= 1.2 mg/ dl
PaO2 >= 60 Torr or SpO2 >= 93 % (room air)
6. estimated survival more than 90 dayes
7. Written informed consent obtained
1. Prior cancer chemotherapy
2. Prior radiation therapy during last 14 days
3. Receiving anti-emetic medication during last 72 hours
4. Vomitting at entry
5. Nausea Grade 2 or more (CTCAE ver. 4) at entry
6. Local or systemic infection requiring treatment
7. Severe comorbid condition such as GI bleeding, ileus, heart disease, glaucoma, diabetes
8. History of severe hypersensitivity
9. Severe psychological problem
10. Pregnant or lactating woman, or woman not going to contracept
11. HBsAg positive
12. Judged as ineligible by treating physiscian
330
1st name | |
Middle name | |
Last name | Koji Matsumoto |
Hyogo Cancer Center
Medical Oncology
13-70, Kitaojji-cho, Akashi
078-929-1151
kojmatsu@hp.pref.hyogo.jp
1st name | |
Middle name | |
Last name | Shinichiro Nakamura |
West Japan Oncology Group
WJOG datacenter
Namba Plaza Bldg.304-1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
06-6633-7400
datacenter@wjog.jp
West Japan Oncology Group
None
Self funding
NO
2012 | Year | 09 | Month | 11 | Day |
Published
Completed
2012 | Year | 09 | Month | 08 | Day |
2012 | Year | 10 | Month | 29 | Day |
2012 | Year | 11 | Month | 21 | Day |
2014 | Year | 11 | Month | 20 | Day |
2012 | Year | 09 | Month | 11 | Day |
2023 | Year | 01 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010437
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