UMIN-CTR Clinical Trial

Public title

A non-randomized confirmatory study of definitive chemoradiotherapy including salvage treatment in patients with clinical stage II/III esophageal carcinoma (JCOG 0909,EC-CRT+Salvage-sP3)

Acronym

A non-randomized confirmatory study of definitive chemoradiotherapy including salvage treatment in patients with clinical stage II/III esophageal carcinoma (JCOG 0909,EC-CRT+Salvage-sP3)

Scientific Title

A non-randomized confirmatory study of definitive chemoradiotherapy including salvage treatment in patients with clinical stage II/III esophageal carcinoma (JCOG 0909,EC-CRT+Salvage-sP3)

Scientific Title:Acronym

A non-randomized confirmatory study of definitive chemoradiotherapy including salvage treatment in patients with clinical stage II/III esophageal carcinoma (JCOG 0909,EC-CRT+Salvage-sP3)

Region

Japan

Condition

esophageal neoplasm

Classification by specialty

Gastroenterology	Gastrointestinal surgery	Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of deffenitive chemoradiotherapy with 5-FU plus cisplatin including salvage treatment in patients with clinical stage II/ III esophageal cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase III

Primary outcomes

Proportion of 3-year overall survival

Key secondary outcomes

progression-free survival, complete response rate, adverse events, delayed toxicity, salvage treatment related toxicity, esophagectomy-free survival

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Maneuver

Interventions/Control_1

Chemoradiotherapy consists of 5-FU (1,000 mg/m2, day1-4, day29-32), cisplatin (75 mg/m2, day1,29) and radiotherapy (50.4 Gy/28Fr), followed by adittional two courses chemotherapy with 5-FU (1,000 mg/m2, day1-4) plus cisplatin (75 mg/m2, day1). Salvage therapy including salvage surgery and/or salvage endoscopic mucosal resection is applied if the patient has residual tumor or recurrent tumor after definitive chemoradiotherapy.

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

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma
2) All lesions located in the thoracic esophagus
3) Clinical stageII or III without T4
4) Aged 20 to 75 years old
5) ECOG Performance status 0 or 1
6) No previous therapy against esophageal cancer except for complete resection by EMR/ESD with either pT1a-LPM(pM2)/pT1a-MM(M3) disease or pT1a-MM(M3) disease without vascular infiltration
7) Neither previous chemotherapy, chemoradiotherapy, nor radiotherapy against any cancers except for hormonal therapy for prostate cancer with more than 5 years of disease-free interval
8) Adequate organ functions
9) Patients do not have a preference to receive a surgical resection as an initial therapy including preoperative chemotherapy, but agree to receive a salvage treatment including surgery when the disease is residual or recurrent
10) 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
8) Diabetes mellitus with HbA1c of 7.0% or higher
9) Uncontrollable hypertention
10) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months.
11) Interstitial pneumonia, fibroid lung, or severe emphysema
12) With a history of cerebrovascular disorder within 6 months
13) Drug allergy for iodic drug

Target sample size

95

Name of lead principal investigator

1st name
Middle name
Last name	Yuko Kitagawa

Organization

Keio University School of Medicine

Division name

Department of Surgery

Zip code

Address

35, Shinanoi-Chou, Shinjuku-ku, Tokyo 160-8582, Japan.

TEL

Email

Name of contact person

1st name
Middle name
Last name	Yoshinori Ito

Organization

JCOG0909 Coordinating Office

Division name

National Cnacer Center Hosipital, division of radiation oncology

Zip code

Address

5-1-1Tsukiji, Chuo-ku, Tokyo, 105-0043, Japan.

TEL

03-3542-2511

Homepage URL

http://www.jcog.jp/

Email

JCOG_sir@ml.jcog.jp

Institute

Japan Clinical Oncology Group(JCOG)

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）
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）
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）
東京医科歯科大学（東京都）
がん研究会有明病院（東京都）
虎の門病院（東京都）
東海大学医学部（神奈川県）
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）
富山大学付属病院（富山県）
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）
大阪大学医学部（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）
広島大学病院（広島県）
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）
九州大学病院（福岡県）

Date of disclosure of the study information

2010

Year

04

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2010

Year

03

Month

10

Day

Date of IRB

Anticipated trial start date

2010

Year

04

Month

01

Day

Last follow-up date

2020

Year

10

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

04

Month

26

Day

Last modified on

2014

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=R000004179