Chemoradiotherapy With or Without Enteral Nutrition for Locally Advanced Thoracic Esophageal Carcinoma

Phase 3

Completed

• Conditions: Enteral Nutrition Therapy; Chemoradiotherapy; Esophageal Squamous Cell Carcinoma
• Interventions: Drug: Enteral nutrition; Radiation: radiotherapy

• Registration Number: NCT02399306
• Lead Sponsor: Sichuan Cancer Hospital and Research Institute

Brief Summary

This is a randomized, prospective, multicenter study.

Detailed Description

This is a randomized, prospective, multicenter study. The aim of this study was to compare the changes of body weight,survival,toxicity,quality of life and opportunistic infection frequency in Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma between and after chemoradiotherapy with or without enteral nutrition therapy.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-03-17
• Study First Submitted QC: 2015-03-25
• Study First Posted: 2015-03-26
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-16
• Last Update Posted: 2020-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 222

Inclusion Criteria

• 18 to 75 years old
• male or femalePathologically or cytologically proven esophageal squamous cell carcinoma
• Clinical stage II or stage III
• PG-SGA≧2
• Karnofsky performance score(KPS) ≧70
• Estimated life expectancy of at least 12 weeks
• Hemoglobin≥90.0g/dL,white blood cell count（WBC）≥ 4000 cells/mm³,Platelet count≥100,000 cells/mm³
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times upper limit of normal,bilirubin normal
• Creatinine normal OR creatinine clearance ≥ 60 mL/min
• Patients have good compliance to treatment and follow-up of acceptance
• Forced expiratory volume in one second（FEV1） ≥ 1.5 litre or ≥ 75% of the reference value
• the functions of the heart, kidney, liver were basically normal, with no chemotherapy and radiotherapy contraindications

Exclusion Criteria

• Patients with severely bowel function impaired or can not tolerate enteral nutrition
• Patients with serious gastrointestinal obstruction, be unable to take food by mouth and can not / do not want to a feeding tube inserted
• Patients have no risk of malnutrition
• Patients have severe malnutrition (weight loss >10% or <30 g/L, BMI<18.5 kg/m2 or hemoglobin<90 g/L before the treatment
• Patients who have severe vomiting, gastrointestinal bleeding, intestinal obstruction
• Patients can not tolerate chemotherapy and radiotherapy
• Patients who have distant metastasis
• The primary tumor or lymph node already received surgical treatment (except for biopsy);
• Patient who received radiotherapy for primary tumor or lymph node;
• Patient who received chemotherapy or immunotherapy;
• Patient who suffered from other malignant tumor;
• Patient who have taken other drug test within 1 month;
• Pregnant woman or Lactating Women and Women in productive age who refuse to take contraception in observation period;
• Subject with a severe allergic history or idiosyncratic;
• Subject with severe pulmonary and cardiopathic disease history;
• Refuse or incapable to sign the informed consent form of participating this trial;
• Drug abuse or alcohol addicted;
• Subject with a Personality or psychiatric diseases, people with no legal capacity or people with limited capacity for civil conduct;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	radiotherapy	chemoradiotherapy with Enteral Nutrition intervention
Arm A	Enteral nutrition	chemoradiotherapy with Enteral Nutrition intervention
Arm B	radiotherapy	chemoradiotherapy

Primary Outcome Measures

Name	Time	Method
Body Weight Change from baseline to the end of treatment	up to 1 month after the treatment	Body weight change from baseline to the end of treatment = body weight at the end of treatment - baseline body weight.

Secondary Outcome Measures

Name	Time	Method
Blood biochemical examination	up to 1 month after the treatment	albumin, haemoglobin,et al
short-term effect	up to 1 month after the treatment	objective remission rate
Overall Survival	at least 2 years	overall survival
Completion rate of chemoradiotherapy	up to 1 month after the treatment	The proportion of people who complete all treatment as required
Maximum Body Weight Change during treatment	up to 1 month after the treatment	Maximum body weight change during treatment= the lowest body weight during treatment - baseline body weight.
Grade 3-5 toxicity	up to 1 month after the treatment	Grade 3-5 adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0 andthe criteria of the Radiation Therapy Oncology Group ，such as esophagitis、pneumonitis 、hematologic toxicity and infection rate

Trial Locations

Locations (1)

Sichuan Cancer Hospital & Institute; 🇨🇳 Chengdu, Sichuan, China