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

Esophageal Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00190554
• Other study ID #: JCOG9907
• Secondary ID: C000000223
• Status: Terminated
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: September 20, 2016
• Start date: May 2000
• Est. completion date: May 2009

Study information

• Verified date: September 2016
• Source: Japan Clinical Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 330
• Est. completion date: May 2009
• Est. primary completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Neoplasms

Intervention

Drug:
• Surgery +(Cisplatin 80 mg/?+5FU 800mg/?×5days)×2

• (Cisplatin 80 mg/?+5FU 800mg/?×5days)×2+Surgery

Locations

Country	Name	City	State
Japan	Juntendo University School of Medicine	Bunkyo-ku,Hongo,3-1-3	Tokyo
Japan	Tokyo Medical and Dental University Hospital	Bunkyo-ku,Yushima,1-5-45	Tokyo
Japan	Chiba University, Graduate School of Medicine	Chiba,Chuo-ku,Inohana,1-8-1	Chiba
Japan	National Cancer Center Hospital	Chuo-ku,Tsukiji,5-1-1	Tokyo
Japan	Hiroshima City Asa Hospital	Hiroshima,Asakitaku,KabeminamiHiroshima,2-1-1	Hiroshima
Japan	Tokyo Dental College Ichikawa General Hospital	Ichikawashi,Sugano,5-11-13	Chiba
Japan	Tokai University School of Medicine	Isehara,Shimokasuya,143	Kanagawa
Japan	National Cancer Center Hospital East	Kashiwa,Kashiwanoha,6-5-1	Chiba
Japan	Kurume University School of Medicine	Kurume,Asahi-machi,67	Fukuoka
Japan	Kyoto University Hospital	Kyoto,Sakyo-ku,Syogoinkawara,54	Kyoto
Japan	National Hospital Organization Shikoku Cancer Center	Matsuyama,Horinouchi,13	Ehime
Japan	National Hospital Organization Tokyo Medical Center	Meguro-ku,Higashigaoka,2-5-1	Tokyo
Japan	Toranomon Hospital	Minato-ku,Toranomon,2-2-2	Tokyo
Japan	Iwate Medical University	Morioka,Uchimaru,19-1	Iwate
Japan	Aichi Cancer Center Hospital	Nagoya,Chikusa-ku,Kanokoden,1-1	Aichi
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	Tokyo Women's Medical University	Shinjuku-ku,Kawada-cho,8-1	Tokyo
Japan	Keio University Hospital	Shinjuku-ku,Shinanomachi,35	Tokyo
Japan	Sizuoka Cancer Center	Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007	Shizuoka
Japan	Tochigi Cancer Center	Utsunomiya,Yohnan,4-9-13	Tochigi
Japan	Kanagawa Cancer Center	Yokohama,Asahi-ku,Nakao,1-1-2	Kanagawa

Sponsors (2)

Lead Sponsor	Collaborator
Japan Clinical Oncology Group	Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival		year	No
Secondary	Overall survival		year	No
Secondary	Toxicity of chemotherapy		year	Yes
Secondary	Operative morbidity		year	Yes

External Links

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