UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015938
Receipt number R000018547
Scientific Title Phase II study of chemoradiotherapy with 5-FU plus cisplatin followed by S-1 for clinical stage IA esophageal cancer (definitive chemoradiotherapy)
Date of disclosure of the study information 2014/12/15
Last modified on 2021/06/30 19:09:00

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Basic information

Public title

Phase II study of chemoradiotherapy with 5-FU plus cisplatin followed by S-1 for clinical stage IA esophageal cancer (definitive chemoradiotherapy)

Acronym

Phase II study of chemoradiotherapy with 5-FU plus cisplatin followed by S-1 for clinical stage IA esophageal cancer

Scientific Title

Phase II study of chemoradiotherapy with 5-FU plus cisplatin followed by S-1 for clinical stage IA esophageal cancer (definitive chemoradiotherapy)

Scientific Title:Acronym

Phase II study of chemoradiotherapy with 5-FU plus cisplatin followed by S-1 for clinical stage IA esophageal cancer

Region

Japan


Condition

Condition

esophageal cancer (clinical stage IA)

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of concurrent chemoradiotherapy with 5-FU plus cisplatin followed by S-1 for clinical stage IA (UICC-TNM ver.7.0) esophageal cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Progression free survival

Key secondary outcomes

Overall survival, Complete Response Rate, Preservation rate, Relative dose intensity, Adverse event


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Concurrent chemoradiotherapy with 5-FU and cisplatin followed by S-1

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

1) Clinical stage IA (cT1a or cT1bN0M0)esophageal cancer (Histologically proven squamous cell carcinoma of the esophagus)
2) Aged >= 20 years old
3) ECOG PS of 0 or 1
4) Adequate food intake
5) No esophageal cancer including HGIN out of radiation field
6) Adequate organ functions
7) Written informed consent

Key exclusion criteria

1) Previous treatment with pyrimidine fluoride drug or platinum within 5 years
2) With active diseases (interstitial pneumonia, fibroid lung, intestinal obstruction, uncontrollable diabetes millutus or hypertentsion, history of myocardial infarction within 6 months, or unstable angina pectoris, liver cirrhosis, renal failure)
3) Simultaneous or metachronous cancers, with the exception of tumor curable with therapy before diagnosis of esophageal cancer
4) History of severe allergic reactions to pyrimidine fluoride drug or platinum
5) Active infection
6) Positive HBs antigen
7) Previous radiotherapy to chest
8) With severe diarrhea
9) Psychosis
10) Pregnant or lactating women, women of childbearing potential or women who like to have children in future
11) Patients requiring the administration of flucytosine, phenytoin or warfarin potassium
12) Any patients judged by the investigator to be unfit to participate in the study

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Tetsuo
Middle name
Last name Takehara

Organization

Osaka University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

565-0871

Address

2-2 Yamadaoka, Suita, Osaka 565-0871, Japan

TEL

06-6879-5111

Email

takehara@gh.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name Yoshito
Middle name
Last name Hayashi

Organization

Osaka University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

565-0871

Address

2-2 Yamadaoka, Suita, Osaka 565-0871, Japan

TEL

06-6879-5111

Homepage URL


Email

y.hayashi@gh.med.osaka-u.ac.jp


Sponsor or person

Institute

Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Osaka University Clinical Research Review Committee

Address

2-15 Yamadaoka, Suita, Osaka 565-0871, Japan

Tel

06-6879-5111

Email

rinri@hp-crc.med.osaka-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2014 Year 12 Month 15 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

No longer recruiting

Date of protocol fixation

2014 Year 10 Month 24 Day

Date of IRB

2014 Year 10 Month 24 Day

Anticipated trial start date

2014 Year 12 Month 16 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 12 Month 14 Day

Last modified on

2021 Year 06 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018547


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name