Percutaneous Endoscopic Gastrostomy Before Definitive Concurrent Chemoradiation Therapy for Esophageal Squamous Cell Carcinoma
- Conditions
- Esophageal Squamous Cell Carcinoma
- Interventions
- Combination Product: Concurrent chemoradiotherapy combined with enteral feeding by percutaneous endoscopic gastrostomy
- Registration Number
- NCT04380480
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experiment Concurrent chemoradiotherapy combined with enteral feeding by percutaneous endoscopic gastrostomy 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.
- Primary Outcome Measures
Name Time Method Percentage of Recent Weight Loss From baseline until the end of concurrent chemoradiotherapy, an average of 8 weeks
- Secondary Outcome Measures
Name Time Method Change in nutrition status assessed by blood test 1 year Change in nutrition status will be assessed by hemoglobin, serum albumin, pre-albumin test. The patient-generated subjective global assessment will also be used to measure patients' nutrition status
Quality of life measured by WHO Quality of Life-100 questionnaire 1 year Rate of grade 3-4 radiation esophagitis 1 year Rate of grade 3-4 bone marrow suppression 1 year Overall survival 3 years Rate of grade 3-4 radiation pneumonitis， 1 year Objective response rate 2 months Changes of participants' intestinal flora assessed by blood, urine and stool test 1 year
Trial Locations
- Locations (1)
Hui Liu
🇨🇳Guangzhou, Guangdong, China