Unique ID issued by UMIN | UMIN000005534 |
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Receipt number | R000006563 |
Scientific Title | Randomized Phase II trial of Palonosetron/Dexamethasone concurrent therapy with prevention of CINV according to chemotherapy including Oxaliplatin or Irinotecan in patients with advanced colorectal cancer. |
Date of disclosure of the study information | 2011/05/09 |
Last modified on | 2012/05/01 16:42:53 |
Randomized Phase II trial of Palonosetron/Dexamethasone concurrent therapy with prevention of CINV according to chemotherapy including Oxaliplatin or Irinotecan
in patients with advanced colorectal cancer.
Randomized Phase II trial of Palonosetron/Dexamethasone concurrent therapy with prevention of CINV according to chemotherapy including Oxaliplatin or Irinotecan
in patients with advanced colorectal cancer. (PALODEX-C)
Randomized Phase II trial of Palonosetron/Dexamethasone concurrent therapy with prevention of CINV according to chemotherapy including Oxaliplatin or Irinotecan
in patients with advanced colorectal cancer.
Randomized Phase II trial of Palonosetron/Dexamethasone concurrent therapy with prevention of CINV according to chemotherapy including Oxaliplatin or Irinotecan
in patients with advanced colorectal cancer. (PALODEX-C)
Japan |
advanced colorectal cancer
Hematology and clinical oncology |
Malignancy
NO
To evaluate the efficacy and safety of Palonosetron/Dexamethasone and Palonosetron/ Loss Dexamethasone of concurrent therapy with prevention of CINV according to chemotherapy.
Safety,Efficacy
Phase II
Delayed(24-120hr) complete response rate
Acute(0-24hr) complete response rate
All(0-120hr) complete response rate
Acute and delayed and Overall
Complete Protection rate
Total Control rate
No vomiting rate
No nausea rate
Vomiting episodes
Severity of nausea
Rescue medication use rate
Adverse event
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is not considered as adjustment factor.
YES
2
Treatment
Medicine |
Group A(Normal Group of Dexamethasone)
Day1
Dexamethasone 9.9mg/body (i.v)
Palonosetron 0.75mg/body
Day2-3
Dexamethasone 8mg/body (p.o)
This administration method repeated
4 courses.
Group B(Loss Group of Dexamethasone)
Day1
Dexamethasone 9.9mg/body (i.v)
Palonosetron 0.75mg/body
Day2-3
Dexamethasone 2mg/body (p.o)
This administration method repeated
4 courses.
20 | years-old | <= |
Not applicable |
Male and Female
(1) Histopathological confirmation of colorectal cancer(Adenocarcinoma)
(2) Unresectable or recurrent colorectal cancer
(3) No prior chemotherapy
(4) Chemotherapy including Oxaliplatin or Irinotecan
(5) ECOG performance status of 0,1
(6) Age 20< or =
(7) Sufficient organ functions
(8) Written informed consent
(1) Severe complications
(2) Obstraction of the gastric outlet or bowel
(3) Symptomatic brain metastases
(4) Massive pleural or abdominal effusion
(5) Nervous tic
(6) Hypersensitivity or severe drug allergy for 5-HT3RA
(7) Hypersensitivity or severe drug allergy for dexamethasone.
(8) Serious drug hypersensitivity
(9) Emetic episodes or CTCAE grade 2< or = nausea
(10) Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding.
(11) Any other cases who are regarded as inadequate for study enrollmet by investigators
80
1st name | |
Middle name | |
Last name | Takao Tamura |
Nara Hospital Kinki University Faculty of Medicine
Department of Medical Oncology
1248-1 Otodachou, Ikomasi, Nara, Japan
+81-743-77-0880
1st name | |
Middle name | |
Last name | Takao Tamura |
Nara Hospital Kinki University Faculty of Medicine
Department of Medical Oncology
1248-1 Otodachou, Ikomasi, Nara, Japan
+81-743-77-0880
http://www.kindainara.com/
ttamura@nara.med.kindai.ac.jp
Nara Hospital Kinki University Faculty of Medicine
Nara Hospital Kinki University Faculty of Medicine
Self funding
NO
近畿大学医学部奈良病院(奈良県)
2011 | Year | 05 | Month | 09 | Day |
Unpublished
Preinitiation
2011 | Year | 03 | Month | 01 | Day |
2011 | Year | 05 | Month | 01 | Day |
2011 | Year | 04 | Month | 30 | Day |
2012 | Year | 05 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006563
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