A Trial of Chemotherapy Before and After Surgery for Stage II,III Esophageal Squamous Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00190554
Recruitment Status : Terminated
First Posted : September 19, 2005
Last Update Posted : September 22, 2016
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group

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

Condition or disease Intervention/treatment Phase
Esophageal Neoplasms Carcinoma, Squamous Cell Drug: Surgery +(Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2 Drug: (Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2+Surgery Phase 3

Detailed Description:
The previous study JCOG9204 showed that postoperative adjuvant chemotherapy with cisplatin and fluorouracil has a detectable preventive effect on relapse in patients with esophageal squamous cell carcinoma compared with surgery alone.(J Clin Oncol 2003;21:4592-4596) Therefore the standard treatment for stage II and III esophageal cancer is adjuvant chemotherapy after surgery.

Study Type : Interventional  (Clinical Trial)
Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : May 2000
Actual Primary Completion Date : May 2004
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Disease free survival [ Time Frame: year ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: year ]
  2. Toxicity of chemotherapy [ Time Frame: year ]
  3. Operative morbidity [ Time Frame: year ]

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00190554

Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan, 464-8681
Chiba University, Graduate School of Medicine
Chiba,Chuo-ku,Inohana,1-8-1, Chiba, Japan, 260-8670
Tokyo Dental College Ichikawa General Hospital
Ichikawashi,Sugano,5-11-13, Chiba, Japan, 2728513
National Cancer Center Hospital East
Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan, 277-8577
National Hospital Organization Shikoku Cancer Center
Matsuyama,Horinouchi,13, Ehime, Japan, 790-0007
Kurume University School of Medicine
Kurume,Asahi-machi,67, Fukuoka, Japan, 830-0011
Hiroshima City Asa Hospital
Hiroshima,Asakitaku,KabeminamiHiroshima,2-1-1, Hiroshima, Japan, 731-0293
Iwate Medical University
Morioka,Uchimaru,19-1, Iwate, Japan, 020-8505
Tokai University School of Medicine
Isehara,Shimokasuya,143, Kanagawa, Japan, 259-1193
Kanagawa Cancer Center
Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, Japan, 241-0815
Kyoto University Hospital
Kyoto,Sakyo-ku,Syogoinkawara,54, Kyoto, Japan, 606-8507
Niigata University Medical and Dental Hospital
Niigata,Asahimachi-dori,1-754, Niigata, Japan, 951-8520
Niigata Cancer Center Hospital
Niigata,Kawagishi-cho,2-15-3, Niigata, Japan, 951-8566
Osaka National Hospital
Osaka,Chuo-ku,Hoenzaka,2-1-14, Osaka, Japan, 540-0006
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, Japan, 537-8511
Sizuoka Cancer Center
Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007, Shizuoka, Japan, 411-8777
Tochigi Cancer Center
Utsunomiya,Yohnan,4-9-13, Tochigi, Japan, 320-0834
Juntendo University School of Medicine
Bunkyo-ku,Hongo,3-1-3, Tokyo, Japan, 113-0033
Tokyo Medical and Dental University Hospital
Bunkyo-ku,Yushima,1-5-45, Tokyo, Japan, 113-8519
National Cancer Center Hospital
Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan, 104-0045
National Hospital Organization Tokyo Medical Center
Meguro-ku,Higashigaoka,2-5-1, Tokyo, Japan, 152-8902
Toranomon Hospital
Minato-ku,Toranomon,2-2-2, Tokyo, Japan, 105-8470
Tokyo Women's Medical University
Shinjuku-ku,Kawada-cho,8-1, Tokyo, Japan, 162-8666
Keio University Hospital
Shinjuku-ku,Shinanomachi,35, Tokyo, Japan, 160-8582
Sponsors and Collaborators
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Study Chair: Nobutoshi Ando, M.D. Tokyo Dental College Ichikawa General Hospital

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00190554     History of Changes
Other Study ID Numbers: JCOG9907
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016

Keywords provided by Japan Clinical Oncology Group:
esophageal cancer
squamous cell carcinoma
neoadjuvant chemotherapy
esophageal squamous cell carcinoma

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs