UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005534
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

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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 or person

Institute

Nara Hospital Kinki University Faculty of Medicine

Institute

Department

Personal name



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

Value
https://center6.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