UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study of TAS102 for advanced/recurrent esophageal cancer resistant/intolerable to 5-FU, Platinum compounds, and Taxane
Title of the study (Brief title)	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	Manabu Muto
Organization	Kyoto University Hospital
Division name	Department of Clinical oncology
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	Hiroi Kasai
Organization	Kyoto University Hospital
Division name	Institute for Advancement of Clinical and Translational Science
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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