A Prospective, Multicenter, Randomized Controlled Study to Compare Chemoradiotherapy With or Without Enteral Nutrition Intervention for Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

Sichuan Cancer Hospital and Research Institute1 site in 1 country222 target enrollmentSeptember 2014

ConditionsEsophageal Squamous Cell Carcinoma Enteral Nutrition Therapy Chemoradiotherapy

InterventionsEnteral nutrition radiotherapy

DrugsEnteral nutrition

Overview

Phase: Phase 3
Intervention: Enteral nutrition
Conditions: Esophageal Squamous Cell Carcinoma
Sponsor: Sichuan Cancer Hospital and Research Institute
Enrollment: 222
Locations: 1
Primary Endpoint: Body Weight Change from baseline to the end of treatment
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2014

End Date

October 2017

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sichuan Cancer Hospital and Research Institute

Responsible Party

Principal Investigator

LI TAO

Section Head

Sichuan Cancer Hospital and Research Institute

Eligibility Criteria

Inclusion Criteria

•18 to 75 years old
•male or femalePathologically or cytologically proven esophageal squamous cell carcinoma
•Clinical stage II or stage III
•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

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;