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

Sun Yat-sen University

Status and phase: Completed; Phase 2

Conditions: Esophageal Squamous Cell Carcinoma

Treatments: Combination Product: Concurrent chemoradiotherapy combined with enteral feeding by percutaneous endoscopic gastrostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04380480

GASTO-1059

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 1 patient group

Experiment

Experimental group

Description:

One or two weeks before CCRT, all patients will undergo a percutaneous endoscopic gastrostomy (PEG) to be administered enteral nutrition support(30-35 kcal/kg of energy, 1.2-1.5g/kg of protein and electrolyte supplementation each day). Nutritional supplements will be administered till 1 month after CCRT. All patients will receive definitive radiotherapy combined with three cycles of S-1 (40mg/2, BID, po) on D1-14, D22-35, D43-56.

Treatment:

Combination Product: Concurrent chemoradiotherapy combined with enteral feeding by percutaneous endoscopic gastrostomy