OBJECTIVE: To evaluate the clinical value of prophylactic radiotherapy for esophageal carcinoma after curative operation. METHODS:495 esophageal squamous cell cancer patients who had undergone radical resection were randomized by the envelope method into a surgery alone group (S, 275) and a surgery plus radiotherapy group (S + R, 220). Radiation treatment was started 3 - 4 weeks after operation. The portals encompassed the whole mediastinum and bilateral supraclavicular areas. A mid-plane dose of 50 approximately 60 Gy in 20 approximately 30 fractions over 5 approximately 6 weeks was delivered. RESULTS: 1. Survival rate: the overall 5-year survival rate was 39.4%. Those of S alone and S + R groups were 37.1% and 41.3% (P = 0.447 4). The 5-year survival rate for Stage III patients were 13.1% in S alone group and 35.1% in R + S group (P = 0.002 7), 2. Pattern of failure: The incidence of local recurrence intra-thoracic lymph node metastasis, anastomotic recurrence and extra-thoracic lymph node metastasis in S + R group (16.2%, 0.5% and 3.1%) were lower than those (25.9%, 5.8% and 13.2%) (P < 0.05) in S alone group and 3. COMPLICATIONS: the anastomotic stricture frequencies were similar in the two groups (S 1.8%; S + R 4.1%). CONCLUSION: 1. Prophylactic radiotherapy is able to improve the survival rate of stage III patients treated by radical resection, 2. Postoperative radiotherapy is able to reduce the incidence of failure by recurrence in the intra-thoracic lymph nodes and anastomotic recurrence to where radiation therapy had been given, 3. Postoperative radiotherapy does not increase the incidence of anastomotic stricture.
RCT Entities:
OBJECTIVE: To evaluate the clinical value of prophylactic radiotherapy for esophageal carcinoma after curative operation. METHODS: 495 esophageal squamous cell cancerpatients who had undergone radical resection were randomized by the envelope method into a surgery alone group (S, 275) and a surgery plus radiotherapy group (S + R, 220). Radiation treatment was started 3 - 4 weeks after operation. The portals encompassed the whole mediastinum and bilateral supraclavicular areas. A mid-plane dose of 50 approximately 60 Gy in 20 approximately 30 fractions over 5 approximately 6 weeks was delivered. RESULTS: 1. Survival rate: the overall 5-year survival rate was 39.4%. Those of S alone and S + R groups were 37.1% and 41.3% (P = 0.447 4). The 5-year survival rate for Stage III patients were 13.1% in S alone group and 35.1% in R + S group (P = 0.002 7), 2. Pattern of failure: The incidence of local recurrence intra-thoracic lymph node metastasis, anastomotic recurrence and extra-thoracic lymph node metastasis in S + R group (16.2%, 0.5% and 3.1%) were lower than those (25.9%, 5.8% and 13.2%) (P < 0.05) in S alone group and 3. COMPLICATIONS: the anastomotic stricture frequencies were similar in the two groups (S 1.8%; S + R 4.1%). CONCLUSION: 1. Prophylactic radiotherapy is able to improve the survival rate of stage III patients treated by radical resection, 2. Postoperative radiotherapy is able to reduce the incidence of failure by recurrence in the intra-thoracic lymph nodes and anastomotic recurrence to where radiation therapy had been given, 3. Postoperative radiotherapy does not increase the incidence of anastomotic stricture.