Unique ID issued by UMIN | UMIN000019268 |
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Receipt number | R000022283 |
Scientific Title | A phase II study of TAS102 for advanced/recurrent esophageal cancer resistant/intolerable to 5-FU, Platinum compounds, and Taxane |
Date of disclosure of the study information | 2015/10/13 |
Last modified on | 2018/05/08 21:51:11 |
A phase II study of TAS102 for advanced/recurrent esophageal cancer resistant/intolerable to 5-FU, Platinum compounds, and Taxane
A phase II study of TAS102 for advanced/recurrent esophageal cancer resistant/intolerable to 5-FU, Platinum compounds, and Taxane (ECTAS study)
A phase II study of TAS102 for advanced/recurrent esophageal cancer resistant/intolerable to 5-FU, Platinum compounds, and Taxane
A phase II study of TAS102 for advanced/recurrent esophageal cancer resistant/intolerable to 5-FU, Platinum compounds, and Taxane (ECTAS study)
Japan |
Unresectable, advanced or recurrent esophageal cancer
Gastroenterology |
Malignancy
NO
To investigate the progression-free survival rate at 3 months in patients with unresectable, advanced or recurrent esophageal cancer who are resistant or intolerable to 5-FU, platinum compounds, and taxane
Efficacy
Exploratory
Pragmatic
Phase II
Progression-free survival rate at 3 months
Progression-free survival rate at 6 months
Progression-free survival
Overall survival
Overall response rate
Disease control rate
Safety and tolerability
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Each treatment cycle is 28 days. TAS-102 will be administered twice daily
for 5 days with 2 days rest for 2 weeks, repeated every 28 days.
TAS-102 (35 mg/m2/dose) will be administered orally twice daily (BID) on
Days 1 through 5, with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5, followed by a recovery period from Day 6 through Day 7. TAS-102 will again be administered orally BID on Day 8 through 12, with the first dose administered in the morning of Day 8 of each cycle and the last dose administered in the evening of Day 12, followed by a recovery period from Day 13 through Day 28.
20 | years-old | <= |
Not applicable |
Male and Female
A patient must meet all of the following inclusion criteria to be eligible for enrollment in this study:
1. Has definitive histologically or cytologically confirmed esophageal cancer (squamous cell carcinoma, adeno-squamous cell carcinoma, or basaloid squamous cell carcinoma)
2. Is diagnosed as noncurative.
3. Is diagnosed as resistant or intolerable to 5-FU, platinum compounds, and taxane.
4. Is >= 20 years of age.
5. Has Eastern Cooperative Group (ECOG) performance status of 0 or 1.
6. Has adequate organ function as defined by the following laboratory values:
i. Absolute neutrophil count of >= 1,500/mm3.
ii. Hemoglobin value of >= 8.0 g/dL.
iii. Platelet count >= 75,000/mm3.
iv. Total serum bilirubin of <= 1.5 mg/dL.
v. Aspartate aminotransferase (AST) <= 3.0 x upper limit of normal (ULN); if liver function abnormalities are due to underlying liver metastasis, AST <= 5 x ULN.
vi. Alanine aminotransferase (ALT) <= 3.0 x upper limit of normal (ULN); if liver function abnormalities are due to underlying liver metastasis, ALT <= 5 x ULN.
vii. Serum creatinine of <= 1.5 mg/dL.
7. Has provided written informed consent prior to performance of any study procedure.
Exclude a patient from this study if any of the following conditions are observed:
1. Has high risk of fistula of the esophagus
2. Has a serious illness or medical condition(s)
3. Has had treatment with any of the following within the specified time frame prior to study drug administration:
i. Major surgery within prior 4 weeks.
ii. Minor surgery within prior 2 weeks.
iii. Extended field radiation within prior 4 weeks or limited field radiation within prior 2 weeks.
iv. Any anticancer therapy within prior 3 weeks.
v. Any targeted therapies using antibodies including investigational agents received within prior 4 weeks.
vi. Any investigational therapies except for investigational agents of v. within prior 4 weeks, excluding therapy with bisphosphonates and anti-RANKL antibodies.
4. Has received TAS-102.
5. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies (excluding alopecia, dysgeusia, nail damage, and skin pigmentation of any grades, and neurotoxicity of Grade 1-2).
6. Is a pregnant or lactating female.
7. Has a desire for a child
8. Is inappropriate for entry into this study in the judgment of the Investigator.
40
1st name | |
Middle name | |
Last name | Manabu Muto |
Kyoto University Hospital
Department of Clinical oncology
54 Kawaharacho, Shogoin, Sakyo-ku Kyoto,606-8507, JAPAN
075-751-4592
tas102_office@ml.kuhp.kyoto-u.ac.jp
1st name | |
Middle name | |
Last name | Hiroi Kasai |
Kyoto University Hospital
Institute for Advancement of Clinical and Translational Science
54 Kawaharacho, Shogoin, Sakyo-ku Kyoto,606-8507, JAPAN
075-751-4722
tas102_office@ml.kuhp.kyoto-u.ac.jp
Kyoto University Hospital
TAIHO PHARMACEUTICAL Co.,Ltd.
Other
JAPAN
NO
平成27年9月30日 第10回
京都大学医学部附属病院(京都府)
埼玉県立がんセンター(埼玉県)
千葉県がんセンター(千葉県)
国立がん研究センター中央病院(東京都)
大阪府立成人病センター(大阪府)
国立がん研究センター東病院(千葉県)
静岡県立静岡がんセンター(静岡県)
2015 | Year | 10 | Month | 13 | Day |
Unpublished
Completed
2015 | Year | 07 | Month | 31 | Day |
2015 | Year | 10 | Month | 15 | Day |
2017 | Year | 03 | Month | 30 | Day |
2017 | Year | 05 | Month | 26 | Day |
2017 | Year | 07 | Month | 10 | Day |
2017 | Year | 09 | Month | 28 | Day |
2015 | Year | 10 | Month | 07 | Day |
2018 | Year | 05 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022283
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