UMIN-CTR Clinical Trial

Public title

A randomized controlled trial of chemotherapy with 5FU and cisplatin before and after surgery for stage II,III squamous cell carcinoma of the thoracic esophagus (JCOG9907)

Acronym

A randomized controlled trial of chemotherapy with 5FU and cisplatin before and after surgery for stage II,III squamous cell carcinoma of the thoracic esophagus (JCOG9907)

Scientific Title

A randomized controlled trial of chemotherapy with 5FU and cisplatin before and after surgery for stage II,III squamous cell carcinoma of the thoracic esophagus (JCOG9907)

Scientific Title:Acronym

A randomized controlled trial of chemotherapy with 5FU and cisplatin before and after surgery for stage II,III squamous cell carcinoma of the thoracic esophagus (JCOG9907)

Region

Japan

Condition

esophageal squamous cell carcinoma

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To determine whether chemotherapy before surgery makes better outcome than chemotherapy after surgery in patients with esophageal squamous cell carcinoma

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase III

Primary outcomes

Disease free survival

Key secondary outcomes

Overall survival, Toxicity of chemotherapy, Operaive morbidity

Study type

Interventional

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

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Maneuver

Interventions/Control_1

Surgery +(Cisplatin 80 mg/m2 +5FU 800mg/m2 x5days) x2

Interventions/Control_2

(Cisplatin 80 mg/m2 +5FU 800mg/m2 x5days) x2 +Surgery

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

Not applicable

Age-upper limit

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) histologically proven squamous cell carcinoma of the thoracic esophagus
(2) pathologic stages IIa, IIb, III except T4
(3) an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
(4)no previous history of chemtherapy nor radiotherapy
(5) an essentially normal clinical laboratory profile (white blood cell count or WBC, >=4,000 /mm3; hemoglobin or Hb, >=10g/dl; platelet count or Plt, >=100,000 /mm3; total serum bilirubin<=1.2 mg/dl; aspartate aminotransaminase or AST and alanine aminotransaminase or ALT no higher than twice normal; creatinine or CRTN, <=1.2 mg/dl; creatinine clearance or CCr, >=60 ml/minute; and arterial oxygen tension or PaO2, >=65 torr
(6) oral or written informed consent obtained before randomization

Key exclusion criteria

(1)severe heart diseases
(2)uncontrolable hyper tension or diabetes mellitus
(3)severe pulmonary dysfunction
(4)HBs positive
(5)active bacterial infection
(6)synchronous or metachronous (within 5 years) malignancy
(7)pregnant female
(8)psychiatric medication

Target sample size

330

Name of lead principal investigator

1st name
Middle name
Last name	Nobutoshi Ando, M.D.

Organization

Tokyo Dental College Ichikawa General Hospital

Division name

Department of Surgery

Zip code

Address

5-11-13, Sugano, Ichikawashi, Chiba 272-8513 Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name	Nobutoshi Ando, M.D.

Organization

JCOG9907 Coordinating Office

Division name

Department of Surgery, Tokyo Dental College Ichikawa General Hospital

Zip code

Address

5-11-13, Sugano, Ichikawashi, Chiba 272-8513 Japan

TEL

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

YES

Study ID_1

NCT00190554

Org. issuing International ID_1

ClinicalTrials.gov by NLM

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

岩手医科大学（岩手県）
栃木県立がんセンター（栃木県）
国立がんセンター東病院（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）
虎の門病院（東京都）
順天堂大学医学部（東京都）
東海大学医学部（神奈川県）
神奈川県立がんセンター（神奈川県）　　　
新潟県立がんセンター新潟病院（新潟県）
新潟大学医学部（新潟県）
静岡がんセンター（静岡県）
愛知県がんセンター（愛知県）
京都大学医学部付属病院（京都府）
大阪府立成人病センター（大阪府）
国立病院大阪医療センター（大阪府）
広島市立安佐市民病院（広島県）
国立病院四国がんセンター（愛媛県）　　
国立病院九州がんセンター（福岡県）
久留米大学医学部（福岡県）

Date of disclosure of the study information

2005

Year

09

Month

13

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/21879261

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

Recruitment status

Completed

Date of protocol fixation

2000

Year

03

Month

08

Day

Date of IRB

Anticipated trial start date

2000

Year

05

Month

01

Day

Last follow-up date

2009

Year

05

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2005

Year

09

Month

13

Day

Last modified on

2014

Year

02

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000288