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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000005534
Receipt No. 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

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Basic information
Public 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.
Acronym 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)
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.
Scientific Title:Acronym 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)
Region
Japan

Condition
Condition advanced colorectal cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of Palonosetron/Dexamethasone and Palonosetron/ Loss Dexamethasone of concurrent therapy with prevention of CINV according to chemotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Delayed(24-120hr) complete response rate
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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.
Interventions/Control_2 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.
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 Male and Female
Key inclusion criteria (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
Key exclusion criteria (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
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takao Tamura
Organization Nara Hospital Kinki University Faculty of Medicine
Division name Department of Medical Oncology
Zip code
Address 1248-1 Otodachou, Ikomasi, Nara, Japan
TEL +81-743-77-0880
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takao Tamura
Organization Nara Hospital Kinki University Faculty of Medicine
Division name Department of Medical Oncology
Zip code
Address 1248-1 Otodachou, Ikomasi, Nara, Japan
TEL +81-743-77-0880
Homepage URL http://www.kindainara.com/
Email ttamura@nara.med.kindai.ac.jp

Sponsor
Institute Nara Hospital Kinki University Faculty of Medicine
Institute
Department

Funding Source
Organization Nara Hospital Kinki University Faculty of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 近畿大学医学部奈良病院(奈良県)

Other administrative information
Date of disclosure of the study information
2011 Year 05 Month 09 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 Preinitiation
Date of protocol fixation
2011 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 04 Month 30 Day
Last modified on
2012 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006563

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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