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: May 31, 2007
Last verified: May 2007
  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

Secondary Outcome Measures:
  • Overall survival
  • Toxicity of chemotherapy
  • Operative morbidity

Estimated Enrollment: 330
Study Start Date: May 2000
Estimated Study Completion Date: May 2009
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
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
1-1,Kanokoden,Chikusa-ku,Nagoya, Aichi, Japan, 464-8681
Chiba University, Graduate School of Medicine
1-8-1,Inohana,Chuo-ku,Chiba, Chiba, Japan, 260-8670
Tokyo Dental College Ichikawa General Hospital
5-11-13, Sugano, Ichikawashi, Chiba, Japan, 2728513
National Cancer Center Hospital East
6-5-1,Kashiwanoha,Kashiwa, Chiba, Japan, 277-8577
National Hospital Organization Shikoku Cancer Center
13,Horinouchi,Matsuyama, ,, Ehime, Japan, 790-0007
Kurume University School of Medicine
67,Asahi-machi,Kurume, Fukuoka, Japan, 830-0011
Hiroshima City Asa Hospital
2-1-1,Kabeminami,Asakita-ku,Hiroshima, Hiroshima, Japan, 731-0293
Iwate Medical University
19-1,Uchimaru,Morioka, Iwate, Japan, 020-8505
Kanagawa Cancer Center
1-1-2,Nakao,Asahi-ku,Yokohama, Kanagawa, Japan, 241-0815
Tokai University School of Medicine
143,Shimokasuya,Isehara, Kanagawa, Japan, 259-1193
Kyoto University Hospital
54,Syogoinkawara,Sakyo-ku,Kyoto, Kyoto, Japan, 606-8507
Niigata University Medical and Dental Hospital
1-754,Asahimachi-dori,Niigata, Niigata, Japan, 951-8520
Niigata Cancer Center Hospital
2-15-3,Kawagishi-cho,Niigata, Niigata, Japan, 951-8566
Osaka Medical Center for Cancer and Cardiovascular Diseases
1-3-3,Nakamichi,Higashinari-ku,Osaka, Osaka, Japan, 537-8511
Osaka National Hospital
2-1-14,Hoenzaka,Chuo-ku,Osaka, Osaka, Japan, 540-0006
Sizuoka Cancer Center
1007,Shimonagakubo,Nagaizumi-cho,Sunto-gun, Shizuoka, Japan, 411-8777
Tochigi Cancer Center
4-9-13,Yohnan,Utsunomiya, Tochigi, Japan, 320-0834
Tokyo Medical and Dental University Hospital
1-5-45,Yushima,Bunkyo-ku, Tokyo, Japan, 113-8519
Toranomon Hospital
2-2-2,Toranomon,Minato-ku, Tokyo, Japan, 105-8470
National Hospital Organization Tokyo Medical Center
2-5-1,Higashigaoka,Meguro-ku, Tokyo, Japan, 152-8902
Juntendo University School of Medicine
3-1-3,Hongo,Bunkyo-ku, Tokyo, Japan, 113-0033
Keio University Hospital
35,Shinanomachi,Shinjuku-ku, Tokyo, Japan, 160-8582
National Cancer Center Hospital
5-1-1,Tsukiji,Chuo-ku, Tokyo, Japan, 104-0045
Tokyo Women's Medical University
8-1,Kawada-cho,Shinjuku-ku, Tokyo, Japan, 162-8666
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:
No publications provided by Japan Clinical Oncology Group

Additional 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: May 31, 2007
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:
Neoplasms
Carcinoma
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
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 23, 2014