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

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

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

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.

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