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

This study has been terminated.
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:
NCT00190554
First received: September 13, 2005
Last updated: September 20, 2016
Last verified: September 2016
  Purpose
To determine whether chemotherapy before surgery makes better outcome than chemotherapy after surgery in patients with esophageal squamous cell carcinoma

Condition Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:
  • Disease free survival [ Time Frame: year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: year ] [ Designated as safety issue: No ]
  • Toxicity of chemotherapy [ Time Frame: year ] [ Designated as safety issue: Yes ]
  • Operative morbidity [ Time Frame: year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 330
Study Start Date: May 2000
Study Completion Date: May 2009
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00190554

Locations
Japan
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
Investigators
Study Chair: Nobutoshi Ando, M.D. Tokyo Dental College Ichikawa General Hospital
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00190554     History of Changes
Other Study ID Numbers: JCOG9907  C000000223 
Study First Received: September 13, 2005
Last Updated: September 20, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

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

ClinicalTrials.gov processed this record on December 02, 2016