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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006773
Receipt No. R000008011
Scientific Title Randomized phase II study of aprepitant in patients with colorectal cancer receiving FOLFOX, FOLFIRI, or XELOX chemotherapy regimen.
Date of disclosure of the study information 2011/11/25
Last modified on 2011/12/06

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Basic information
Public title Randomized phase II study of aprepitant in patients with colorectal cancer receiving FOLFOX, FOLFIRI, or XELOX chemotherapy regimen.
Acronym The Kagoshima Aprepitant Study for Colorectal Cancer (KASCC)
Scientific Title Randomized phase II study of aprepitant in patients with colorectal cancer receiving FOLFOX, FOLFIRI, or XELOX chemotherapy regimen.
Scientific Title:Acronym The Kagoshima Aprepitant Study for Colorectal Cancer (KASCC)
Region
Japan

Condition
Condition colon and rectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of aprepitant combined with the standard therapy of 5HT3-receptor antagonist and dexamethasone in patients with colorectal cancer receiving FOLFOX or FOLFILI or XELOX chemotherapy regimen.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes The percentage of patients with complete
response (defined as no emetic episode and no rescue therapy)
Key secondary outcomes 1)The percentage of patients with complete
protection (defined as no emesis, no rescue therapy and no significant nausea)
2)The percentage of patients with no emesis
3)The percentage of patients with no nausia
4)The percentage of patients with no significant nausea
5)Time to treatment failure (defined as time to first emetic episode or time to first use of rescue therapy)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
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 Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Aprepitant; 125 mg PO on day 1
Aprepitant; 80 mg PO on days 2 to 3
5HT3-receptor antagonist; IV on day 1
Dexamethasone; 6.6 mg IV on day 1
Dexamethasone; 4 mg PO on days 2 to 3
Interventions/Control_2 5HT3-receptor antagonist; IV on day 1
Dexamethasone; 9.9 mg IV on day 1
Dexamethasone; 8 mg PO on days 2 to 3
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)Age: 20 years old and over
2) Colorectal cancer patient scheduled to be treated with their first FOLFOX FOLFILI or XELOX chemotherapy, including oxaliplatin at 85 mg/m2 or more, or irinotecan at 150 mg/m2 or more
Key exclusion criteria 1) Patient with a serious hepatic insufficiency or renal failure
2) Patient with nausea or vomiting within 24 hours prior to chemotherapy
3) Patient treated with anti-emetic agents within 24 hours prior to chemotherapy
4) Patient with a risk of nausea or vomiting for other reasons (e.g. central nervous system tumors, gastrointestinal obstruction, active peptic ulcer, brain metastasis)
5) Patient unable to be administered dexamethasone for 3 days due to comorbidity, such as out-of-control diabetes mellitus
6) Pregnant women or Patient with pregnancy desire or Lactating women
7) Patient receiving pimozide
8)Patient judged inappropriate for this study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shoji Natsugoe
Organization Kagoshima University Graduate School of Medical and Dental Sciences
Division name Department of Digestive Surgery, Breast and Thyroid Surgery
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima, Japan
TEL 099-275-5358
Email

Public contact
Name of contact person
1st name
Middle name
Last name Sumiya Ishigami
Organization Kagoshima University Graduate School of Medical and Dental Sciences
Division name Department of Digestive Surgery, Breast and Thyroid Surgery
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima, Japan
TEL 099-275-5360
Homepage URL
Email

Sponsor
Institute Department of Digestive Surgery, Breast and Thyroid Surgery, Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2011 Year 11 Month 25 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 Open public recruiting
Date of protocol fixation
2011 Year 07 Month 08 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
2012 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 11 Month 25 Day
Last modified on
2011 Year 12 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008011

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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