UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019268
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

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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 or person

Institute

Kyoto University Hospital

Institute

Department

Personal name



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

Value
https://center6.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