Esophageal Squamous Cell Carcinoma
Conditions
Keywords
esophageal squamous cell carcinoma, percutaneous endoscopic gastrostomy, concurrent chemoradiotherapy, enteral nutrition support
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.
Interventions
COMBINATION_PRODUCTConcurrent 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.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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 0-1. * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Recent Weight Loss | From baseline until the end of concurrent chemoradiotherapy, an average of 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 radiation pneumonitis， | 1 year | — |
| 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 |
| Objective response rate | 2 months | — |
| Overall survival | 3 years | — |
| Changes of participants' intestinal flora assessed by blood, urine and stool test | 1 year | — |
| Rate of grade 3-4 bone marrow suppression | 1 year | — |
Countries
China
Outcome results
None listed