A Trial of Chemotherapy Before and After Surgery for Stage II,III Esophageal Squamous Cell Carcinoma
NCT ID: NCT00190554
Last Updated: 2016-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
330 participants
INTERVENTIONAL
2000-05-31
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Surgery +(Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2
(Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2＋Surgery
Eligibility Criteria
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Inclusion Criteria
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
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
75 Years
ALL
No
Sponsors
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Ministry of Health, Labour and Welfare, Japan
OTHER_GOV
Japan Clinical Oncology Group
OTHER
Principal Investigators
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Nobutoshi Ando, M.D.
Role: STUDY_CHAIR
Tokyo Dental College Ichikawa General Hospital
Locations
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Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, Japan
Chiba University, Graduate School of Medicine
Chiba,Chuo-ku,Inohana,1-8-1, Chiba, Japan
Tokyo Dental College Ichikawa General Hospital
Ichikawashi,Sugano,5-11-13, Chiba, Japan
National Cancer Center Hospital East
Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama,Horinouchi,13, Ehime, Japan
Kurume University School of Medicine
Kurume,Asahi-machi,67, Fukuoka, Japan
Hiroshima City Asa Hospital
Hiroshima,Asakitaku,KabeminamiHiroshima,2-1-1, Hiroshima, Japan
Iwate Medical University
Morioka,Uchimaru,19-1, Iwate, Japan
Tokai University School of Medicine
Isehara,Shimokasuya,143, Kanagawa, Japan
Kanagawa Cancer Center
Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, Japan
Kyoto University Hospital
Kyoto,Sakyo-ku,Syogoinkawara,54, Kyoto, Japan
Niigata University Medical and Dental Hospital
Niigata,Asahimachi-dori,1-754, Niigata, Japan
Niigata Cancer Center Hospital
Niigata,Kawagishi-cho,2-15-3, Niigata, Japan
Osaka National Hospital
Osaka,Chuo-ku,Hoenzaka,2-1-14, Osaka, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, Japan
Sizuoka Cancer Center
Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007, Shizuoka, Japan
Tochigi Cancer Center
Utsunomiya,Yohnan,4-9-13, Tochigi, Japan
Juntendo University School of Medicine
Bunkyo-ku,Hongo,3-1-3, Tokyo, Japan
Tokyo Medical and Dental University Hospital
Bunkyo-ku,Yushima,1-5-45, Tokyo, Japan
National Cancer Center Hospital
Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan
National Hospital Organization Tokyo Medical Center
Meguro-ku,Higashigaoka,2-5-1, Tokyo, Japan
Toranomon Hospital
Minato-ku,Toranomon,2-2-2, Tokyo, Japan
Tokyo Women's Medical University
Shinjuku-ku,Kawada-cho,8-1, Tokyo, Japan
Keio University Hospital
Shinjuku-ku,Shinanomachi,35, Tokyo, Japan
Countries
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References
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Hirao M, Ando N, Tsujinaka T, Udagawa H, Yano M, Yamana H, Nagai K, Mizusawa J, Nakamura K; Japan Esophageal Oncology Group/Japan Clinical Oncology Group. Influence of preoperative chemotherapy for advanced thoracic oesophageal squamous cell carcinoma on perioperative complications. Br J Surg. 2011 Dec;98(12):1735-41. doi: 10.1002/bjs.7683. Epub 2011 Sep 14.
Related Links
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Related Info
Other Identifiers
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C000000223
Identifier Type: -
Identifier Source: secondary_id
JCOG9907
Identifier Type: -
Identifier Source: org_study_id
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