A Prospective Randomized Phase III Trial Comparing Trimodality Therapy (Cisplatin, 5-FU, Radiotherapy, and Surgery) to Surgery Alone for Esophageal Cancer

Fecha de inicio: 1 de octubre de 1997

Patients with histologically documented untreated squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (below 20 cm) or gastro-esophageal junction and with less than 2 cm distal spread into the gastric cardia were eligible. No evidence of distant metastatic disease by history and physical examination Upper endoscopy with biopsy, computed tomography (CT) of the chest and upper abdomen, and pulmonary function studies are required. Bone scan is required for alkaline phosphatase more than 3X the institutional normal value. Bronchoscopy is required if the primary tumor was adjacent to the trachea or left main stem bronchus. Patients are required to have: granulocyte counts ≥1,800/mL platelet count ≥ 100,000/mL creatinine clearance ≥ 50 mL/min Esophageal ultrasound (EUS) and preresection staging by thoracoscopy (ts) and laparoscopy/minilaparotomy (ls), including biopsy of celiac axis and lesser curvature are recommended Tumors must be considered surgically resectable (T1-3, NX), including regional thoracic lymph node (N1) metastases. Patients with supraclavicular lymph nodes measuring ≤ 1.5 cm by CT (not palpable) are eligible. Patients with lymph node metastases to levels 15 to 20 (predominantly celiac axis and paracardial nodes) ≤1.5 cm by CT. Patients may not have previously received chemotherapy or radiation therapy for this tumor or any radiation therapy that would overlap the radiation fields required for this malignancy. Patients with previous malignancies are eligible if more than 5 years had elapsed from diagnosis without evidence of tumor recurrence. There can be no other serious illness that would limit survival to less than 2 years, or psychiatric condition that would prevent compliance with treatment or informed consent. Patients with uncontrolled or severe cardio- vascular disease,pulmonary disease, oractive infections are excluded. Pregnant patients are excluded. Informed consent is required for all patients.