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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000223
Receipt No. R000000288
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)
Date of disclosure of the study information 2005/09/13
Last modified on 2014/02/21

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Basic information
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
Condition esophageal squamous cell carcinoma
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
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

Assessment
Primary outcomes Disease free survival
Key secondary outcomes Overall survival, Toxicity of chemotherapy, Operaive morbidity

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 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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Japan Clinical Oncology Group(JCOG)
Institute
Department

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 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
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)

Other administrative information
Date of disclosure of the study information
2005 Year 09 Month 13 Day

Related information
URL releasing protocol
Publication of results Published

Result
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

Progress
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
Other related information

Management information
Registered date
2005 Year 09 Month 13 Day
Last modified on
2014 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000288

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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