A Trial of Chemotherapy Before and After Surgery for Stage II,III Esophageal Squamous Cell Carcinoma
This study has been terminated.
Sponsor:
Japan Clinical Oncology Group
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
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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 |
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:
- histologically proven squamous cell carcinoma of the thoracic esophagus
- pathologic stages IIa, IIb, III except T4
- an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- no previous history of chemotherapy nor radiotherapy
- 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
- oral or written informed consent obtained before randomization
Exclusion Criteria:
- severe heart diseases
- uncontrollable hyper tension or diabetes mellitus
- severe pulmonary dysfunction
- HBs positive
- active bacterial infection
- synchronous or metachronous (within 5 years) malignancy
- pregnant female
- psychiatric medication
Contacts and Locations
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 Diseases Esophageal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Squamous Cell Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Head and Neck Neoplasms 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 May 23, 2013