UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014683
Receipt number R000017003
Scientific Title Phase II study of chemoradiotherapy with S-1 plus cisplatin for clinical stage IA esophageal cancer (definitive chemoradiotherapy)
Date of disclosure of the study information 2014/07/30
Last modified on 2023/02/02 18:53:14

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Basic information

Public title

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

Acronym

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

Scientific Title

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

Scientific Title:Acronym

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

Region

Japan


Condition

Condition

clinical stage IA esophageal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of concurrent chemoradiotherapy with S-1 plus cisplatin 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

Complete response rate

Key secondary outcomes

Overall survival, Progression free survival, 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 S-1 and cisplatin

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Histologically proven squamous cell carcinoma, adenosquamous cell carcinoma or basaloid carcinoma of the esophagus
2) Primary lesion are located within the cervical esophagus (Ce) and the abdominal esophagus (Ae)
3) Aged 20 to 80 years old
4) ECOG PS of 0, 1 or 2
5) Clinical stage IA (cT1a or cT1bN0M0) or pT1 which need therapy
6) No need for measurable lesion
7) No previous treatment of esophageal cancer
8) Adequate food intake
9) No palsy of recurrent nerve
10) Adequate organ functions
11) Refused esophagectomy
12) Written informed consent

Key exclusion criteria

1) Simultaneous or metachronous double cancers, with the exception of tumor curable with therapy before diagnosis of esophageal cancer
2) Patients requiring the administration of phenytoin or warfarin potassium
3) Uncontrollable diabetes millutus
4) History of myocardial infarction within 6 months, or unstable angina pectoris or cardiac failure
5) Uncontrollable arrhythmia
6) Patients requiring systemic steroids medication
7) Liver cirrhosis
8) Active bacterial or fungous infection
9) With a history of grade 2-4 allergic reaction by CTCAE version 4.0
10) With grade 2-4 nerve disturbance by CTCAE version 4.0
11) With blood transfusion within 2 weeks and/or active bleeding
12) Interstitial pneumonia, fibroid lung or severe emphysema
13) With a history of allergic reaction to tegafur (FT), gimestat (CDHP) and otastat potassium (Oxo)
14) Psychosis
15) Pregnant or lactating women, women of childbearing potential or men who like to have children in future
16) Any patients judged by the investigator to be unfit to participate in the study

Target sample size

38


Research contact person

Name of lead principal investigator

1st name Sachiko
Middle name
Last name Yamamoto

Organization

Osaka International Cancer Institute

Division name

Department of Gastrointestinal Oncology

Zip code

5418567

Address

3-1-69, Otemae, Chuo-ku, Osaka, Japan

TEL

0669451181

Email

yamamoto-sa@mc.pref.osaka.jp


Public contact

Name of contact person

1st name Sachiko
Middle name
Last name Yamamoto

Organization

Osaka International Cancer Institute

Division name

Department of Gastrointestinal Oncology

Zip code

541-8567

Address

3-1-69, Otemae, Chuo-ku, Osaka, Japan

TEL

0669451181

Homepage URL


Email

yamamoto-sa@mc.pref.osaka.jp


Sponsor or person

Institute

Osaka International Cancer Institute

Institute

Department

Personal name



Funding Source

Organization

Osaka International Cancer Institute

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

Ethics Review Board of Osaka International Cancer Institute

Address

3-1-69, Otemae, Chuo-ku, Osaak, Japan, 541-8567

Tel

+81669451181

Email

yamamoto-sa@mc.pref.osaka.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

地方独立行政法人大阪府立病院機構 大阪国際がんセンター


Other administrative information

Date of disclosure of the study information

2014 Year 07 Month 30 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

2014 Year 06 Month 10 Day

Date of IRB

2014 Year 06 Month 10 Day

Anticipated trial start date

2014 Year 07 Month 30 Day

Last follow-up date

2023 Year 12 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 07 Month 28 Day

Last modified on

2023 Year 02 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017003


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name