UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017668
Receipt number R000020474
Scientific Title A pilot study of definitive chemoradiotherapy using involved-field intensity-modulatd radiation therapy for patients with clinical stage IB-IIIC (non T4) esophageal carcinoma
Date of disclosure of the study information 2015/07/23
Last modified on 2019/11/27 15:50:55

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A pilot study of definitive chemoradiotherapy using involved-field intensity-modulatd radiation therapy for patients with clinical stage IB-IIIC (non T4) esophageal carcinoma

Acronym

A pilot study of definitive chemoradiotherapy using involved-field intensity-modulatd radiation therapy for patients with clinical stage IB-IIIC (non T4) esophageal carcinoma

Scientific Title

A pilot study of definitive chemoradiotherapy using involved-field intensity-modulatd radiation therapy for patients with clinical stage IB-IIIC (non T4) esophageal carcinoma

Scientific Title:Acronym

A pilot study of definitive chemoradiotherapy using involved-field intensity-modulatd radiation therapy for patients with clinical stage IB-IIIC (non T4) esophageal carcinoma

Region

Japan


Condition

Condition

Esophageal neoplasm

Classification by specialty

Gastroenterology Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of definitive chemoradiotherapy using involved-field intensity-modulated radiation therapy for clinical stage IB-IIIC (non T4) esophageal carcinoma

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Complete response rate

Key secondary outcomes



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

Chemoradiotherapy consists of 5-FU (1,000 mg/m2, day 1-4, day 29-32), cisplatin (75 mg/m2, day 1, 29) and involved-field intensity-modulated radiation therapy (50.4 Gy/28 fr), followed by adittional two courses chemotherapy with 5-FU (1,000 mg/m2, day 1-4) plus cisplatin (75 mg/m2, day 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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma in thoracic esophagus
2)Patients refuse to receive or are unfit for a surgical resection
3) Clinical stage IB-IIIC except for cT4 (TNM 7th)
4) Aged 20 to 80 years old
5) ECOG Performance status 0 or 1
6) Adequate organ functions
7) Written informed consent

Key exclusion criteria

1) Simultaneous or metachronous (within 5 years) double cancers , with the exception of intramucosal tumor curable with local therapy
2) Active infection requiring systemic therapy
3) Fever over 38 degrees Celsius
4) Pregnant or lactating women or women of childbearing potential
5) Psychosis
6) Patients requiring systemic steroids medication
7) Serum HBs antigen positive within 1 year
8) Poorly controlled diabetes mellitus
9) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months.
10) Interstitial pneumonia, fibroid lung, or severe emphysema
11) History of cerebrovascular disorder within 6 months
12) Connective tissue disease
13) History of a surgical resection for esophagus

Target sample size

12


Research contact person

Name of lead principal investigator

1st name Masahiro
Middle name
Last name Hiraoka

Organization

Graduate School of Medicine, Kyoto University

Division name

Department of Radiation Oncology and Image-Applied Therapy

Zip code

6068507

Address

54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Kyoto

TEL

075-751-3762

Email

hiraok@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Katsuyuki
Middle name
Last name Sakanaka

Organization

Graduate School of Medicine, Kyoto University

Division name

Department of Radiation Oncology and Image-Applied Therapy

Zip code

6068371

Address

Sakyo-ku,

TEL

075-751-3762

Homepage URL


Email

sakanaka@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN

Tel

(tel)075-753-4680

Email

ethcom@kuhp.kyoto-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

2015 Year 07 Month 23 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

2017 Year 06 Month 24 Day

Date of IRB

2015 Year 06 Month 24 Day

Anticipated trial start date

2017 Year 06 Month 24 Day

Last follow-up date

2018 Year 06 Month 23 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 05 Month 25 Day

Last modified on

2019 Year 11 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020474


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name