A Prospective, Phase II Study of Percutaneous Endoscopic Gastrostomy Before Definitive Concurrent Chemoradiation Therapy in Patients With Esophageal Squamous Cell Carcinoma
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Sun Yat-sen University
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Percentage of Recent Weight Loss
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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-
- •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
Outcomes
Primary Outcomes
Percentage of Recent Weight Loss
Time Frame: From baseline until the end of concurrent chemoradiotherapy, an average of 8 weeks
Secondary Outcomes
- Overall survival(3 years)
- Change in nutrition status assessed by blood test(1 year)
- 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)
- Changes of participants' intestinal flora assessed by blood, urine and stool test(1 year)
- Rate of grade 3-4 radiation pneumonitis，(1 year)
- Objective response rate(2 months)
Investigators
Hui Liu
Professor
Sun Yat-sen University