UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017589 |
|---|---|
| Receipt number | 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 15:58:17 |
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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
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
hideki.shimodaira.c4@tohoku.ac.jp
Sponsor or person
Institute
Tohoku Clinical Oncology Research and Education Society (T-CORE)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020373
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