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

Phase 3

Terminated

• Conditions: Esophageal Neoplasms; Carcinoma, Squamous Cell

• Registration Number: NCT00190554
• Lead Sponsor: 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

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 Timeline

• Study Start: 2000-05
• Primary Completion: 2004-05
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-19
• Study Completion: 2009-05
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-09-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 330

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Disease free survival	year

Secondary Outcome Measures

Name	Time	Method
Overall survival	year
Toxicity of chemotherapy	year
Operative morbidity	year

Trial Locations

Locations (24)

National Hospital Organization Shikoku Cancer Center; 🇯🇵 Matsuyama,Horinouchi,13, Ehime, Japan

Kurume University School of Medicine; 🇯🇵 Kurume,Asahi-machi,67, Fukuoka, 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

Tokyo Medical and Dental University Hospital; 🇯🇵 Bunkyo-ku,Yushima,1-5-45, Tokyo, Japan

National Hospital Organization Tokyo Medical Center; 🇯🇵 Meguro-ku,Higashigaoka,2-5-1, Tokyo, Japan

Tokyo Women's Medical University; 🇯🇵 Shinjuku-ku,Kawada-cho,8-1, Tokyo, 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

Aichi Cancer Center Hospital; 🇯🇵 Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan

National Cancer Center Hospital East; 🇯🇵 Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan

Hiroshima City Asa Hospital; 🇯🇵 Hiroshima,Asakitaku,KabeminamiHiroshima,2-1-1, Hiroshima, 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

National Cancer Center Hospital; 🇯🇵 Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan

Toranomon Hospital; 🇯🇵 Minato-ku,Toranomon,2-2-2, Tokyo, Japan

Keio University Hospital; 🇯🇵 Shinjuku-ku,Shinanomachi,35, Tokyo, Japan