Percutaneous Endoscopic Gastrostomy Before Definitive Concurrent Chemoradiation Therapy for Esophageal Squamous Cell Carcinoma

A Prospective, Phase II Study of Percutaneous Endoscopic Gastrostomy Before Definitive Concurrent Chemoradiation Therapy in Patients With Esophageal Squamous Cell Carcinoma

This Phase II randomized study is to determine the efficacy of percutaneous endoscopic gastrostomy before definitive concurrent chemoradiotherapy (CCRT) in Patients with Esophageal Squamous Cell Carcinoma(ESCC) by assessing their weight, nutritional status, performance status and treatment response.

This Phase II randomized study is to determine the efficacy of percutaneous endoscopic gastrostomy before definitive concurrent chemoradiotherapy (CCRT) in Patients with Esophageal Squamous Cell Carcinoma(ESCC) by assessing their weight, nutritional status, performance status and treatment response.

All patients will receive definitive radiotherapy combined with three cycles of S-1 (40mg/2, BID, po) on D1-14, D22-35, D43-56. The primary endpoint is percentage of recent weight loss at the end of CCRT. The secondary endpoints are nutrition status, objective response rate, overall survival, toxicity and intestinal flora changes in blood, urine and stool specimens.

Inclusion Criteria:

• Histologically confirmed esophageal squamous cell carcinoma
• Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Estimated life expectancy of at least 6 months
• No contraindications for chemotherapy or radiotherapy
• Patients and their family signed the informed consents

Exclusion Criteria:

• Severe gastrointestinal impairment or enteral nutrition intolerance
• Severe vomiting, gastrointestinal bleeding or intestinal obstruction
• Severe malnutrition
• Patients with contraindications for percutaneous endoscopic gastrostomy, including uncorrected coagulopathy or thrombocytopenia, varices caused by portal hypertension, or other gastric diseases
• Not suitable for this study judged by researchers