UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000861
Receipt number R000001025
Scientific Title A Randomized PhaseII/III Study of Concurrent Chemoradiotherapy with Low Dose Cisplatin plus 5-FU versus Concurrent Chemoraiotherapy with Standard Dose Cisplatin plus 5-FU for Locally Advanced Unresetable Esophageal Cancer in the Thorax.(JCOG0303)
Date of disclosure of the study information 2007/10/23
Last modified on 2017/11/08 18:05:11

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Basic information

Public title

A Randomized PhaseII/III Study of Concurrent Chemoradiotherapy with Low Dose Cisplatin plus 5-FU versus Concurrent Chemoraiotherapy with Standard Dose Cisplatin plus 5-FU for Locally Advanced Unresetable Esophageal Cancer in the Thorax.(JCOG0303)

Acronym

A Randomized PhaseII/III Study of Concurrent Chemoradiotherapy with Low Dose Cisplatin plus 5-FU versus Concurrent Chemoraiotherapy with Standard Dose Cisplatin plus 5-FU for Locally Advanced Unresetable Esophageal Cancer in the Thorax.(JCOG0303)

Scientific Title

A Randomized PhaseII/III Study of Concurrent Chemoradiotherapy with Low Dose Cisplatin plus 5-FU versus Concurrent Chemoraiotherapy with Standard Dose Cisplatin plus 5-FU for Locally Advanced Unresetable Esophageal Cancer in the Thorax.(JCOG0303)

Scientific Title:Acronym

A Randomized PhaseII/III Study of Concurrent Chemoradiotherapy with Low Dose Cisplatin plus 5-FU versus Concurrent Chemoraiotherapy with Standard Dose Cisplatin plus 5-FU for Locally Advanced Unresetable Esophageal Cancer in the Thorax.(JCOG0303)

Region

Japan


Condition

Condition

Locally advanced unresectable esophageal cancer in the thorax

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safty of concurrent chemoradiotherapy of low dose cisplatin plus 5-FU compared with concurrent chemoradiotherapy of standard dose cisplatin plus 5-FU for locally advanced unresectable thoracic esophageal cancer without distant metastasis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II,III


Assessment

Primary outcomes

overall survival

Key secondary outcomes

complete response rate, treatment completion rate, treatment completion rate by PS, adverse events


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

A: Standard Dose concurrent chemoradiotherapy (RT: 60Gy/30fr/6w; Cisplatin 70mg/m2 on day 1,29; 5-FU 700mg/m2 on days 1-4, 29-32)

Interventions/Control_2

B:Low Dose concurrent chemoradiotherapy (RT: 60Gy/30fr /6w; Cisplatin 4mg/m2 and 5-FU 200mg/m2, 5 days every week, repeatedly for 6 weeks.)

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

1)Esophageal cancer histologically proven by GIF biopsy (squamons cell carcinoma, adenosquamous carcinoma, basaloid carcinoma)
2)Location of the lesion confirmed by esophagogram
i)Lesion mainly located in the thoracic esophagus
ii)Both primary lesion and intramural matastasis do not invade beyond GE junction
3)Radiotherapist determines before registration that irradiation up to 60 Gy can be completed safely.
4)Tumors are judged unresectable by CT and palpation for the following reason.
i)Primary tumor invasion depth T4
ii)Metastatic regional lymph node(s) invasion to adjacent organ.
iii)Metastatic lymph node(s) such as fixed supraclavicular or coeliac lymph node(s) provided according to the location of main tumor.
5)No distant organ metastasis.
6)Neither esophago-airway fistula nor esophago-mediastinal fistula
7)Neither Radiotherapy nor chemotherapy against any cancers. No previous therapy except EMR against esophageal cancer
8)Age from 20 to 75 years
9)Performance status of 0-2
10)Adequate organ function
11)Written informed consent

Key exclusion criteria

1)Simultaneous or metachronous (within 5 years) double cancers
2)Pregnancy or lactation
3)Serious psychiatric illness
4)Steroid treatment
5)HBs antigen positive
6)Uncontrollable diabetes
7)Myocaedial infarcion within 3 months
8)Serious comorbidity
9)Active bacterial or fungous infection

Target sample size

364


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masayuki Shinoda

Organization

Aichi Cancer Center Hospital

Division name

Department of Thoracic Surgery

Zip code


Address

1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan

TEL

052-762-6111

Email



Public contact

Name of contact person

1st name
Middle name
Last name Masayuki Shinoda

Organization

JCOG0303 Coordinating Office

Division name

Department of Thoracic Surgery, Aichi Cancer Center Hospital

Zip code


Address

1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan

TEL

052-762-6111

Homepage URL

http://www.jcog.jp/

Email

JCOG_sir@ml.jcog.jp


Sponsor or person

Institute

Japan Clinical Oncology Group(JCOG)

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

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



Institutions

Institutions

北海道大学病院(北海道)
岩手医科大学(岩手県)
東北大学病院(宮城県)
山形県立中央病院(山形県)
茨城県立中央病院・茨城県地域がんセンター(茨城県)
栃木県立がんセンター(栃木県)
埼玉県立がんセンター(埼玉県)
国立がん研究センター東病院(千葉県)
千葉県がんセンター(千葉県)
千葉大学医学部(千葉県)
総合病院国保旭中央病院(千葉県)
東京歯科大学市川総合病院(千葉県)
国立がん研究センター中央病院(東京都)
東京女子医科大学(東京都)
国立病院機構東京医療センター(東京都)
慶應義塾大学病院(東京都)
昭和大学病院(東京都)
東京医科歯科大学(東京都)
癌研究会有明病院(東京都)
虎の門病院(東京都)
東海大学医学部(神奈川県)
横浜市立市民病院(神奈川県)
新潟県立がんセンター新潟病院(新潟県)
新潟大学医歯学総合病院(新潟県)
佐久総合病院(長野県)
静岡県立総合病院(静岡県)
静岡県立静岡がんセンター(静岡県)
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)
大阪府立病院機構大阪府立成人病センター(大阪府)
国立病院機構大阪医療センター(大阪府)
大阪市立総合医療センター(大阪府)
大阪医科大学(大阪府)
神戸大学医学部(兵庫県)
兵庫県立がんセンター(兵庫県)
広島市立安佐市民病院(広島県)
国立病院機構四国がんセンター(愛媛県)
高知医療センター(高知県)
国立病院機構九州がんセンター(福岡県)
久留米大学医学部(福岡県)
九州大学病院(福岡県)


Other administrative information

Date of disclosure of the study information

2007 Year 10 Month 23 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/25640628

Number of participants that the trial has enrolled


Results

See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website:
http://www.jcog.jp/en/trials/index.html

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

2004 Year 02 Month 20 Day

Date of IRB


Anticipated trial start date

2004 Year 04 Month 01 Day

Last follow-up date

2012 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2007 Year 10 Month 23 Day

Last modified on

2017 Year 11 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001025


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name