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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019268
Receipt No. 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

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Basic information
Public title A phase II study of TAS102 for advanced/recurrent esophageal cancer resistant/intolerable to 5-FU, Platinum compounds, and Taxane
Acronym A phase II study of TAS102 for advanced/recurrent esophageal cancer resistant/intolerable to 5-FU, Platinum compounds, and Taxane (ECTAS study)
Scientific Title A phase II study of TAS102 for advanced/recurrent esophageal cancer resistant/intolerable to 5-FU, Platinum compounds, and Taxane
Scientific Title:Acronym A phase II study of TAS102 for advanced/recurrent esophageal cancer resistant/intolerable to 5-FU, Platinum compounds, and Taxane (ECTAS study)
Region
Japan

Condition
Condition Unresectable, advanced or recurrent esophageal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 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
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Progression-free survival rate at 3 months
Key secondary outcomes Progression-free survival rate at 6 months
Progression-free survival
Overall survival
Overall response rate
Disease control rate
Safety and tolerability

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 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.
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 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.
Key exclusion criteria 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.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Manabu Muto
Organization Kyoto University Hospital
Division name Department of Clinical oncology
Zip code
Address 54 Kawaharacho, Shogoin, Sakyo-ku Kyoto,606-8507, JAPAN
TEL 075-751-4592
Email tas102_office@ml.kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroi Kasai
Organization Kyoto University Hospital
Division name Institute for Advancement of Clinical and Translational Science
Zip code
Address 54 Kawaharacho, Shogoin, Sakyo-ku Kyoto,606-8507, JAPAN
TEL 075-751-4722
Homepage URL
Email tas102_office@ml.kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital
Institute
Department

Funding Source
Organization TAIHO PHARMACEUTICAL Co.,Ltd.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization JAPAN

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 平成27年9月30日 第10回

Institutions
Institutions 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)

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 13 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 Completed
Date of protocol fixation
2015 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 15 Day
Last follow-up date
2017 Year 03 Month 30 Day
Date of closure to data entry
2017 Year 05 Month 26 Day
Date trial data considered complete
2017 Year 07 Month 10 Day
Date analysis concluded
2017 Year 09 Month 28 Day

Other
Other related information

Management information
Registered date
2015 Year 10 Month 07 Day
Last modified on
2018 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022283

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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