Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)
So far, there is no specific clinical guideline for elderly patients (\>75 yr) with esophageal squamous cell carcinoma (ESCC). Patients with locally advanced ESCC were enrolled and randomly assigned to either definitive radiotherapy group (61.2Gy/34Fx） or the chemoradiotherapy group (50.4Gy/28Fx；Paclitaxel plus carboplatin). The primary end point was 3-year overall survival (OS). The second end points included life quality, radiation side effects and 3-yr cancer specific survival.
• Indicates no limit on eligibility based on the sex of participants
• The 76 years old for the minimum age a potential participant must meet to be eligible for the clinical study.
• Esophageal squamous cell carcinoma confirmed by pathology
• No radiotherapy, chemotherapy or other treatments prior to enrollment
• Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a, TxN1M0-1a, TxNxM1a, TxNxM1b (M1b only for supraclavicular lymph node metastasis) (AJCC 6th)
• Use of an effective contraceptive for adults to prevent pregnancy
• No severely abnormal hematopoietic, cardiac, pulmonary, renal, or hepatic function
• No immunodeficiency
• ECOG 0-1.
• Life expectancy of more than 3 months.