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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000017589
Receipt No. R000020373
Scientific Title A phase II study of an oral nucleoside antitumor agent consisting trifluridine and tipiracil hydrochloride for previously fluoropyrimidine-treated elderly patients with unresectable or recurrent colorectal cancer (T-CORE1401)
Date of disclosure of the study information 2015/05/15
Last modified on 2020/05/18

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Basic information
Public title A phase II study of an oral nucleoside antitumor agent consisting trifluridine and tipiracil hydrochloride for previously fluoropyrimidine-treated elderly patients with unresectable or recurrent colorectal cancer (T-CORE1401)
Acronym A phase II study of TAS-102 for elderly patients with unresectable or recurrent colorectal cancer (T-CORE1401)
Scientific Title A phase II study of an oral nucleoside antitumor agent consisting trifluridine and tipiracil hydrochloride for previously fluoropyrimidine-treated elderly patients with unresectable or recurrent colorectal cancer (T-CORE1401)
Scientific Title:Acronym A phase II study of TAS-102 for elderly patients with unresectable or recurrent colorectal cancer (T-CORE1401)
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective is to confirm efficacy and safety of an oral nucleoside antitumor agent consisting trifluridine and tipiracil hydrochloride, TAS-102, for previously fluoropyrimidine-treated elderly patients with unresectable or recurrent colorectal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Progression-free survival (PFS)
Key secondary outcomes Overall survival (OS), time to treatment failure (TTF), overall response rate (ORR), toxicities, associations between efficacy/toxicity and screening score for comprehensive geriatric assessment, and associations between efficacy/toxicity and serum concentrations of trifluridine.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients take orally 35 mg/m2 of a nucleoside antitumor agent consisting trifluridine and tipiracil hydrochloride twice a day (70 mg/m2/day, day 1-5, 8-12, q4w).
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
65 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria Patients are required to fulfill the following criteria for eligibility.
1) Histologically confirmed adenocarcinoma of colon or rectum.
2) One or more target lesions confirmed by CT or other imaging within 28 days before the registration.
3) One or more previous drug treatments including fluoropyrimidine-based regimen.
4) The Eastern Cooperative Oncology Group Performance Status of 0-2.
5) Ingestible.
6) Estimated to survive for three months or more since registration.
7) Written informed consent.
8) Age 65-84.
9) Fulfill the following hematological and biochemical data obtained in the most recent blood test. WBC >= 3,000 /mm3, neutrophils >= 1,500 /mm3, platelets >= 100,000 /mm3, hemoglobin >= 8.0 g/dl, AST =< 100 IU/l, ALT =< 100 IU/l, and total bilirubin =< 2.0 g/dl. Patients should not receive transfusion or granulocyte colony stimulating factor within 14 days before the blood test.
10) Determined to be able to receive the study protocol by the responsible researcher or contributing researchers of this study.
Key exclusion criteria Patients who fulfill the following criteria for exclusion are excluded.
1) Synchronous double cancer or past history of other cancer within 5 years, except curable carcinoma in situ and skin cancer.
2) Active infection and inflammation (the body temperature with >= 38.0 degree of celsius).
3) Active hepatitis.
4) Serious complications or severe complications that require hospitalization for therapy, such as gastrointestinal paresthesia, bowel obstruction, interstitial pneumonia, pulmonary fibrosis, and uncontrollable hypertension, diabetes mellitus, renal dysfunction, liver dysfunction, and hepatic cirrhosis.
5) Chronic diarrhea (>= 4 times a day, or watery).
6) Active gastrointestinal bleeding.
7) Effusion that requires drainage.
8) Thoracotomy, laparotomy, or laparoscopic surgery within 28 days before registration.
9) Receiving medications with psychotropic drugs for mental disorders, or having mental disorders that require medications with psychotropic drugs.
10) Determined to be inappropriate to enter the study by the responsible researcher or contributing researchers, for any other reasons.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chikashi Ishioka
Organization Institute of Development, Aging and Cancer, Tohoku University
Division name Department of Clinical Oncology
Zip code
Address 4-1 Seiryo-machi, Aoba-ku, Sendai-city, Miyagi
TEL 022-717-8543
Email chikashi@tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Shimodaira
Organization Tohoku Clinical Oncology Research and Education Society (T-CORE)
Division name Administration Office
Zip code
Address 2-42 Akebono-machi, Aoba-ku, Sendai-city, Miyagi
TEL 022-717-8599
Homepage URL
Email hideki.shimodaira.c4@tohoku.ac.jp

Sponsor
Institute Tohoku Clinical Oncology Research and Education Society (T-CORE)
Institute
Department

Funding Source
Organization Tohoku Clinical Oncology Research and Education Society (T-CORE)
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2015 Year 05 Month 15 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 Main results already published
Date of protocol fixation
2015 Year 04 Month 30 Day
Date of IRB
2015 Year 04 Month 24 Day
Anticipated trial start date
2015 Year 05 Month 01 Day
Last follow-up date
2017 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 05 Month 15 Day
Last modified on
2020 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020373

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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