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

Sun Yat-sen University63 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Concurrent chemoradiotherapy combined with enteral feeding by percutaneous endoscopic gastrostomyCOMBINATION_PRODUCT

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Hui Liu

Guangzhou, Guangdong, China

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

Change in nutrition status assessed by blood test

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

Time frame: 1 year

Quality of life measured by WHO Quality of Life-100 questionnaire

Time frame: 1 year

Rate of grade 3-4 radiation esophagitis

Time frame: 1 year

Rate of grade 3-4 radiation pneumonitis，

Time frame: 1 year

Rate of grade 3-4 bone marrow suppression

Time frame: 1 year

Objective response rate

Time frame: 2 months

Overall survival

Time frame: 3 years

Changes of participants' intestinal flora assessed by blood, urine and stool test

Time frame: 1 year

Data from ClinicalTrials.gov

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