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

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

This is a randomized, prospective, multicenter study.

Study Overview

• Status: Completed
• Conditions: Esophageal Squamous Cell Carcinoma; Chemoradiotherapy; Enteral Nutrition Therapy
• Intervention / Treatment: Drug: Enteral nutrition; Radiation: radiotherapy

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 Type: Interventional
• Enrollment (Actual): 222
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Sichuan Cancer Hospital & Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; chemoradiotherapy with Enteral Nutrition intervention	Drug: Enteral nutrition; Patients in the Trial Group received concurrent chemoradiotherapy and standardized, whole-course enteral nutrition management.; Radiation: radiotherapy; Patients receive intensity modulated radiation therapy(IMRT) from week 1 to week 7,once a day, 5 times per week. Radiotherapy dose：95% gross tumor volume（GTV-T） 60-66 Gy /30-33f，GTV-N 60-66 Gy /30-33f，CTV-T 50-54 Gy /25-27f，CTV-N 50-54 Gy /25-27f.
Placebo Comparator: Arm B; chemoradiotherapy	Radiation: radiotherapy; Patients receive intensity modulated radiation therapy(IMRT) from week 1 to week 7,once a day, 5 times per week. Radiotherapy dose：95% gross tumor volume（GTV-T） 60-66 Gy /30-33f，GTV-N 60-66 Gy /30-33f，CTV-T 50-54 Gy /25-27f，CTV-N 50-54 Gy /25-27f.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Weight Change from baseline to the end of treatment	Body weight change from baseline to the end of treatment = body weight at the end of treatment - baseline body weight.	up to 1 month after the treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Body Weight Change during treatment	Maximum body weight change during treatment= the lowest body weight during treatment - baseline body weight.	up to 1 month after the treatment
Blood biochemical examination	albumin, haemoglobin,et al	up to 1 month after the treatment
Grade 3-5 toxicity	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	up to 1 month after the treatment
Completion rate of chemoradiotherapy	The proportion of people who complete all treatment as required	up to 1 month after the treatment
short-term effect	objective remission rate	up to 1 month after the treatment
Overall Survival	overall survival	at least 2 years

Collaborators and Investigators

• Sponsor: Sichuan Cancer Hospital and Research Institute
• Collaborators: Shanxi Province Cancer Hospital; Xiangya Hospital of Central South University; Wuhan University; Henan Cancer Hospital; Peking University Cancer Hospital & Institute; Hebei Medical University Fourth Hospital; Shandong Tumor Hospital
• Investigators: Study Chair: TAO LI, MD, PhD, Sichuan Cancer Hospital and Research Institute

Publications and helpful links

General Publications

• Lyu J, Shi A, Li T, Li J, Zhao R, Zhu S, Wang J, Xing L, Yang D, Xie C, Shen L, Zhang H, Zhu G, Wang J, Pan W, Li F, Lang J, Shi H. Effects of Enteral Nutrition on Patients With Oesophageal Carcinoma Treated With Concurrent Chemoradiotherapy: A Prospective, Multicentre, Randomised, Controlled Study. Front Oncol. 2022 Feb 25;12:839516. doi: 10.3389/fonc.2022.839516. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: March 17, 2015
• First Submitted That Met QC Criteria: March 25, 2015
• First Posted (Estimate): March 26, 2015

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Squamous Cell; Esophageal Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
• Other Study ID Numbers: scch2015001