UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039175
Receipt number 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 2024/01/20 10:52:11

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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 or person

Institute

Gifu University

Institute

Department

Personal name



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

119

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

No longer 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

2024 Year 01 Month 20 Day



Link to view the page

Value
https://center6.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