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 |
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)
A phase II study of TAS-102 for elderly patients with unresectable or recurrent colorectal cancer (T-CORE1401)
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)
A phase II study of TAS-102 for elderly patients with unresectable or recurrent colorectal cancer (T-CORE1401)
Japan |
colorectal cancer
Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Malignancy
NO
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.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Progression-free survival (PFS)
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.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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).
65 | years-old | <= |
85 | years-old | > |
Male and Female
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.
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.
30
1st name | |
Middle name | |
Last name | Chikashi Ishioka |
Institute of Development, Aging and Cancer, Tohoku University
Department of Clinical Oncology
4-1 Seiryo-machi, Aoba-ku, Sendai-city, Miyagi
022-717-8543
chikashi@tohoku.ac.jp
1st name | |
Middle name | |
Last name | Hideki Shimodaira |
Tohoku Clinical Oncology Research and Education Society (T-CORE)
Administration Office
2-42 Akebono-machi, Aoba-ku, Sendai-city, Miyagi
022-717-8599
hideki.shimodaira.c4@tohoku.ac.jp
Tohoku Clinical Oncology Research and Education Society (T-CORE)
Tohoku Clinical Oncology Research and Education Society (T-CORE)
Other
NO
2015 | Year | 05 | Month | 15 | Day |
Unpublished
Main results already published
2015 | Year | 04 | Month | 30 | Day |
2015 | Year | 04 | Month | 24 | Day |
2015 | Year | 05 | Month | 01 | Day |
2017 | Year | 06 | Month | 30 | Day |
2020 | Year | 03 | Month | 31 | Day |
2015 | Year | 05 | Month | 15 | Day |
2020 | Year | 05 | Month | 18 | Day |
Value
https://center6.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 |