UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009880
Receipt number R000011462
Scientific Title A phase II study of intensity modulated radiation therapy (IMRT) with chemotherapy for cervical esophageal cancer (JROSG12-1)
Date of disclosure of the study information 2013/01/28
Last modified on 2018/08/08 08:25:55

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Basic information

Public title

A phase II study of intensity modulated radiation therapy (IMRT) with chemotherapy for cervical esophageal cancer (JROSG12-1)

Acronym

IMRT for cervical esophageal cancer (JROSG12-1)

Scientific Title

A phase II study of intensity modulated radiation therapy (IMRT) with chemotherapy for cervical esophageal cancer (JROSG12-1)

Scientific Title:Acronym

IMRT for cervical esophageal cancer (JROSG12-1)

Region

Japan


Condition

Condition

cervical esophageal cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery Oto-rhino-laryngology
Radiology Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and the safety of chemoradiotherapy with Intensity Modulated Radiation Therapy (IMRT) in patients with cervical esophageal cancer (clinical stage II-III, or IV with supraclavicular LN metastasis, UICC 7th edition)

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

3 year overall survival

Key secondary outcomes

3 year progeression-free survival, 3y esophagus preservation rate, 3y larynx preservation rate, early and late adverse event rates


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

Maneuver

Interventions/Control_1

Concurrent chemoradiotherapy with SIB-IMRT (60Gy (prophylactin LN region: 48Gy)/30fr.) and two cycles of chemotherapy (5-FU 700 mg/m2, day 1-4, CDDP 70 mg/m2, day1, q4w) follwed by two cycles of adjuvant chemotherapy with 5-FU (700 mg/m2, day 1-5) plus cisplatin (70 mg/m2, day 1) repeated every 4 weeks.

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

i) cervical esophageal cancer with pathologically proven squamous cell carcinoma or adenosquamous cell carcinoma;
ii) Clinical stage II-III or IV with supraclavicular LN metastasis (UICC 7th edition, 2009) ;
iii) Aged 20 to 75 years old;
iv) ECOG PS of 0 to 2;
v) No prior chemotherapy against any malignancies;
vi) No prior radiotherapy against head and neck or chest region;
vii) Screening and diagnosis by an otorhinolaryngologist;
viii) Sufficeient organ functions;
ix) Written informed consent.

Key exclusion criteria

i) Simultaneous or metachronous (within 5 years) double cancers;
ii) Systemic infections disease;
iii) Body temperature of 38C or higher;
iv) Women during pregnancy or breast-feeding;
v) Psychiatric disease and/or depression;
vi) Continuous systemic steroids medication;
vii) HBs antigen positive;
viii) Uncontrollable diabetes mellitus;
ix) Uncontrollable hypertension;
x) Myocardial infarction within 6 months or unstable angina pectoris;
xi) Serious complications (interstitial pneumonia, pulmonary fibrosis, COPD, heart failure, etc.);
xii) cerebrovasucular disease within 6 months;
xiii) Histoty of collagen diseases;
xiv) History of surgery of esophagus

Target sample size

44


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasumasa Nishimura

Organization

Medical Faculty, Kinki University.

Division name

Department of Radiation Oncology

Zip code


Address

377-2, Ono-higashi, Osaka-Sayama, Osaka, 589-8511, Japan

TEL

072-368-2388

Email

ynishii@med.kindai.ca.jp


Public contact

Name of contact person

1st name
Middle name
Last name Satoshi Itasaka

Organization

JROSG 12-1 Coordinating Office

Division name

Department of Radiation Oncology, Kurashiki Central Hospital

Zip code


Address

1-1-1 Miwa, Kurashiki, Okayama, 710-8602, Japan

TEL

086-422-0210

Homepage URL

http://www.jrosg.jp/protocol/protocol_list.html

Email

sitasaka@kchnet.or.jp


Sponsor or person

Institute

Japanese Radiation Oncology Study Group(JROSG)

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

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


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



Institutions

Institutions

北海道大学病院(北海道)
札幌医科大学(北海道)
東北大学病院(宮城県)
国立がん研究センター東病院(千葉県)
国立がん研究センター中央病院(東京都)
埼玉県立がんセンター(埼玉県)
神奈川県立がんセンター(神奈川県)
群馬大学病院(群馬県)
愛知県がんセンター中央病院(愛知県)
京都大学医学部附属病院(京都府)
京都府立大学(京都府)
近畿大学医学部(大阪府)
大阪府立病院機構大阪府立成人病センター(大阪府)
広島大学病院(広島県)
兵庫県立がんセンター(兵庫県)
滋賀県立成人病センター(滋賀県)
倉敷中央病院(岡山県)
香川大学(香川県)


Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 28 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

2013 Year 01 Month 15 Day

Date of IRB


Anticipated trial start date

2013 Year 02 Month 16 Day

Last follow-up date

2020 Year 08 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

2013 Year 01 Month 28 Day

Last modified on

2018 Year 08 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011462


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name