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

Japan Clinical Oncology Group

Status and phase

Terminated

Phase 3

Conditions

Carcinoma, Squamous Cell

Esophageal Neoplasms

Treatments

Drug: (Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2＋Surgery

Drug: Surgery +(Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2

Study type

Interventional

Funder types

Other

Identifiers

NCT00190554

C000000223

JCOG9907

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

Under 75 years old

Volunteers

No Healthy Volunteers

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