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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039175
Receipt No. R000044680
Scientific Title Trifluridine/tipiracil(TAS-102)-induced nausea and vomiting in patients with colorectal cancer: a prospective, observational, multicenter study
Date of disclosure of the study information 2020/01/31
Last modified on 2020/02/05

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Basic information
Public title Trifluridine/tipiracil(TAS-102)-induced nausea and vomiting in patients with colorectal cancer: a prospective, observational, multicenter study
Acronym Trifluridine/tipiracil(TAS-102)-induced nausea and vomiting in patients with colorectal cancer: a prospective, observational, multicenter study
Scientific Title Trifluridine/tipiracil(TAS-102)-induced nausea and vomiting in patients with colorectal cancer: a prospective, observational, multicenter study
Scientific Title:Acronym Trifluridine/tipiracil(TAS-102)-induced nausea and vomiting in patients with colorectal cancer: a prospective, observational, multicenter study
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the incidence of nausea and vomiting caused by TAS-102 administration and the actual situation of antiemetic therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of vomiting during the 14 days after starting TAS-102
Key secondary outcomes 1.Incidence of nausea and significant nausea during the 14 days after starting TAS-102
2.Incidence of nausea, significant nausea, and vomiting during the 28 days after starting TAS-102
3.Proportion of patients who receiving prophylactic antiemetic therapy at the start of TAS-102
4.Percentage of patients who receiving antiemetic therapy during the entire study period and number of total days of antiemetic therapy
5.Complete response (no emesis, no rescue medication) rate during the 21 days after starting TAS-102 in patients receiving antiemetic therapy
6.Complete control (no emetic episodes, no rescue medication use, and no significant nausea) rate during the 21 days after starting TAS-102 in patients receiving antiemetic therapy
7.Total control rate (no emetic episodes, no rescue medication use, and no nausea) rate during the 21 days after starting TAS-102 in patients receiving antiemetic therapy
8.Incidence of nausea, significant nausea, and vomiting by type of antiemetics
9.Severity of nausea
10.Severity of anorexia
11.Severity of vomiting
12.Frequency distribution of anorexia, significant anorexia nausea, significant nausea vomiting, and amount of food intake
13.Adverse event (Pro-CTCAE and CTCAE)
14.Reason and frequency of dose reduction
15.Weight fluctuation
16.Patient satisfaction
17.Risk factor analysis for nausea, significant nausea and vomiting for patients who have not received antiemetic therapy

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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.Patients with colorectal cancer who are scheduled to receive TAS-102
2.Patients who can fulfill patient diary correctly.
3.Patients 20 years old or older
4.Written informed consent
Key exclusion criteria 1.Patients with a reduction in the initial dose of TAS-102
2.Patients who need antiemetics at the enrollment.
3.Patients who start taking opioids within 48 hours prior to enrollment
4.Patients with ascites effusion requiring paracentesis
5.Patients with symptomatic brain metastases and cancerous meningitis
6.Patients who have gastrointestinal obstruction
7.Patients who received abdominal or pelvic irradiation within 6 days prior to enrollment
8.Patients who use any drug with antiemetic activity, including NK1RA, 5-HT3RA, corticosteroids, dopamine receptor antagonists, phenothiazine tranquilizers, SSRI, SNRI, SDA, MARTA within 6 days prior to enrollment
9.Other patients who are judged to be inappropriate for the study by the investigator
Target sample size 234

Research contact person
Name of lead principal investigator
1st name Kenji
Middle name
Last name Okita
Organization Sapporo Medical University School of Medicine
Division name Department of Surgery, Surgical Oncology and Science
Zip code 060-8556
Address S1W17, Chuo-ku, Sapporo, Japan
TEL +81-11-611-2111
Email okita@sapmed.ac.jp

Public contact
Name of contact person
1st name Hirotoshi
Middle name
Last name Iihara
Organization Gifu University Hospital
Division name Department of Pharmacy
Zip code 501-1194
Address 1-1 Yanagido, Gifu, Gifu
TEL +81-58-230-6000
Homepage URL
Email dai0920@gifu-u.ac.jp

Sponsor
Institute Gifu University
Institute
Department

Funding Source
Organization None
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 Gifu University
Address 1-1 Yanagido, Gifu, Gifu
Tel +81-58-230-6059
Email rinri@gifu-u.ac.jp

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
2020 Year 01 Month 31 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
2020 Year 01 Month 08 Day
Date of IRB
2020 Year 01 Month 08 Day
Anticipated trial start date
2020 Year 01 Month 31 Day
Last follow-up date
2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Design
A prospective, observational, multicenter study

Patients
Patients with colorectal cancer who are scheduled to receive TAS-102
Survey item
1.Patient's background
2.Nausea, vomiting, rescue medications, anorexia, taste disorders, constipation, diarrhea, insomnia (from patient diary)
3.Patient satisfaction

Management information
Registered date
2020 Year 01 Month 16 Day
Last modified on
2020 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044680

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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