Clinical trial NCT00190554: A Trial of Chemotherapy Before and After Surgery for Stage II,III Esophageal Squamous Cell Carcinoma
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Esophageal Neoplasms
Carcinoma, Squamous Cell
Keywords: esophageal cancer
squamous cell carcinoma
esophagectomy
neoadjuvant chemotherapy
esophageal squamous cell carcinoma
Lead sponsor: Japan Clinical Oncology Group
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
First posted: 2005-09-19
Enrollment: 330
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Disease free survival
timeFrame: year
Secondary outcomes:
measure: Overall survival
timeFrame: year
measure: Toxicity of chemotherapy
timeFrame: year
measure: Operative morbidity
timeFrame: year
Other outcomes:
Locations:
city: Nagoya,Chikusa-ku,Kanokoden,1-1
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Chiba,Chuo-ku,Inohana,1-8-1
country: Japan
facility: Chiba University, Graduate School of Medicine
state: Chiba
city: Ichikawashi,Sugano,5-11-13
country: Japan
facility: Tokyo Dental College Ichikawa General Hospital
state: Chiba
city: Kashiwa,Kashiwanoha,6-5-1
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Matsuyama,Horinouchi,13
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Kurume,Asahi-machi,67
country: Japan
facility: Kurume University School of Medicine
state: Fukuoka
city: Hiroshima,Asakitaku,KabeminamiHiroshima,2-1-1
country: Japan
facility: Hiroshima City Asa Hospital
state: Hiroshima
city: Morioka,Uchimaru,19-1
country: Japan
facility: Iwate Medical University
state: Iwate
city: Isehara,Shimokasuya,143
country: Japan
facility: Tokai University School of Medicine
state: Kanagawa
city: Yokohama,Asahi-ku,Nakao,1-1-2
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Kyoto,Sakyo-ku,Syogoinkawara,54
country: Japan
facility: Kyoto University Hospital
state: Kyoto
city: Niigata,Asahimachi-dori,1-754
country: Japan
facility: Niigata University Medical and Dental Hospital
state: Niigata
city: Niigata,Kawagishi-cho,2-15-3
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata
city: Osaka,Chuo-ku,Hoenzaka,2-1-14
country: Japan
facility: Osaka National Hospital
state: Osaka
city: Osaka,Higashinari-ku,Nakamichi,1-3-3
country: Japan
facility: Osaka Medical Center for Cancer and Cardiovascular Diseases
state: Osaka
city: Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007
country: Japan
facility: Sizuoka Cancer Center
state: Shizuoka
city: Utsunomiya,Yohnan,4-9-13
country: Japan
facility: Tochigi Cancer Center
state: Tochigi
city: Bunkyo-ku,Hongo,3-1-3
country: Japan
facility: Juntendo University School of Medicine
state: Tokyo
city: Bunkyo-ku,Yushima,1-5-45
country: Japan
facility: Tokyo Medical and Dental University Hospital
state: Tokyo
city: Chuo-ku,Tsukiji,5-1-1
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Meguro-ku,Higashigaoka,2-5-1
country: Japan
facility: National Hospital Organization Tokyo Medical Center
state: Tokyo
city: Minato-ku,Toranomon,2-2-2
country: Japan
facility: Toranomon Hospital
state: Tokyo
city: Shinjuku-ku,Kawada-cho,8-1
country: Japan
facility: Tokyo Women's Medical University
state: Tokyo
city: Shinjuku-ku,Shinanomachi,35
country: Japan
facility: Keio University Hospital
state: Tokyo
Study officials:
affiliation: Tokyo Dental College Ichikawa General Hospital
name: Nobutoshi Ando, M.D.
role: STUDY_CHAIR
References:
citation: Hirao M, Ando N, Tsujinaka T, Udagawa H, Yano M, Yamana H, Nagai K, Mizusawa J, Nakamura K; Japan Esophageal Oncology Group/Japan Clinical Oncology Group. Influence of preoperative chemotherapy for advanced thoracic oesophageal squamous cell carcinoma on perioperative complications. Br J Surg. 2011 Dec;98(12):1735-41. doi: 10.1002/bjs.7683. Epub 2011 Sep 14.