UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000223 |
|---|---|
| Receipt number | 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 14:23:38 |
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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
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/
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000288
