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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00190554 |
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Date of registration:
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13/09/2005 |
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Primary sponsor: |
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Public title:
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A Trial of Chemotherapy Before and After Surgery for Stage II,III Esophageal Squamous Cell Carcinoma
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Scientific title:
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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 |
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Date of first enrolment:
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May 2000 |
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Target sample size:
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330 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00190554 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Japan
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Contacts
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Name:
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Nobutoshi Ando, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Tokyo Dental College Ichikawa General Hospital |
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Key inclusion & exclusion criteria
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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 chemotherapy 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
Exclusion Criteria:
1. severe heart diseases
2. uncontrollable 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
Age minimum:
N/A
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Carcinoma, Squamous Cell
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Esophageal Neoplasms
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Intervention(s)
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Drug: (Cisplatin 80 mg/?+5FU 800mg/?×5days)×2+Surgery
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Drug: Surgery +(Cisplatin 80 mg/?+5FU 800mg/?×5days)×2
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Primary Outcome(s)
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Disease free survival
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Secondary Outcome(s)
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Operative morbidity
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Overall survival
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Toxicity of chemotherapy
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Secondary ID(s)
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C000000223
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JCOG9907
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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