BACKGROUND: Despite three decades of debate, no conclusion has been reached concerning the effectiveness of postoperative radiotherapy for resected esophageal carcinoma. From 1986 through 1997, a prospective randomized study was carried out with 495 patients in an attempt to define the value of this therapeutic modality. METHODS: A total of 495 patients with esophageal cancer who had undergone radical resection were randomized by the envelope method into a surgery-alone group (S) of 275 patients and a surgery plus radiotherapy group (S + R) of 220 patients. Radiation treatment was started 3 to 4 weeks after the operation. The portals encompassed the entire mediastinum and bilateral supraclavicular areas. A midplane dose of 50 to 60 Gy in 25 to 30 fractions was delivered over 5 to 6 weeks. RESULTS: The overall 5-year survival rate was 31.7% for the S group and 41.3% (p = 0.4474) for the S + R group. The 5-year survival rates of patients who were lymph node positive were 14.7% and 29.2% (p = 0.0698), respectively. Five-year survival rates of stage III patients were 13.1% and 35.1% (p = 0.0027), respectively. CONCLUSIONS:Postoperative prophylactic radiotherapy improved the 5-year survival rate in esophageal cancer patients with positive lymph node metastases and in patients with stage III disease compared with similar patients who did not receive radiation therapy. These results were almost significant for patients with positive lymph node metastases and highly significant for patients with stage III disease.
RCT Entities:
BACKGROUND: Despite three decades of debate, no conclusion has been reached concerning the effectiveness of postoperative radiotherapy for resected esophageal carcinoma. From 1986 through 1997, a prospective randomized study was carried out with 495 patients in an attempt to define the value of this therapeutic modality. METHODS: A total of 495 patients with esophageal cancer who had undergone radical resection were randomized by the envelope method into a surgery-alone group (S) of 275 patients and a surgery plus radiotherapy group (S + R) of 220 patients. Radiation treatment was started 3 to 4 weeks after the operation. The portals encompassed the entire mediastinum and bilateral supraclavicular areas. A midplane dose of 50 to 60 Gy in 25 to 30 fractions was delivered over 5 to 6 weeks. RESULTS: The overall 5-year survival rate was 31.7% for the S group and 41.3% (p = 0.4474) for the S + R group. The 5-year survival rates of patients who were lymph node positive were 14.7% and 29.2% (p = 0.0698), respectively. Five-year survival rates of stage III patients were 13.1% and 35.1% (p = 0.0027), respectively. CONCLUSIONS: Postoperative prophylactic radiotherapy improved the 5-year survival rate in esophageal cancerpatients with positive lymph node metastases and in patients with stage III disease compared with similar patients who did not receive radiation therapy. These results were almost significant for patients with positive lymph node metastases and highly significant for patients with stage III disease.