Clinical trial NCT02399306: Chemoradiotherapy With or Without Enteral Nutrition for Locally Advanced Thoracic Esophageal Carcinoma
Official title: A Prospective, Multicenter, Randomized Controlled Study to Compare Chemoradiotherapy With or Without Enteral Nutrition Intervention for Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Esophageal Squamous Cell Carcinoma
Enteral Nutrition Therapy
Chemoradiotherapy
Lead sponsor: Sichuan Cancer Hospital and Research Institute
Sponsor class: OTHER
Collaborators: name: Wuhan University
name: Xiangya Hospital of Central South University
name: Shanxi Province Cancer Hospital
name: Shandong Tumor Hospital
name: Henan Cancer Hospital
name: Peking University Cancer Hospital & Institute
name: Hebei Medical University Fourth Hospital
First posted: 2015-03-26
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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;

Primary outcomes:
measure: Body Weight Change from baseline to the end of treatment
timeFrame: up to 1 month after the treatment
Secondary outcomes:
measure: Maximum Body Weight Change during treatment
timeFrame: up to 1 month after the treatment
measure: Blood biochemical examination
timeFrame: up to 1 month after the treatment
measure: Grade 3-5 toxicity
timeFrame: up to 1 month after the treatment
measure: Completion rate of chemoradiotherapy
timeFrame: up to 1 month after the treatment
measure: short-term effect
timeFrame: up to 1 month after the treatment
measure: Overall Survival
timeFrame: at least 2 years
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Cancer Hospital & Institute
state: Sichuan
Study officials:
affiliation: Sichuan Cancer Hospital and Research Institute
name: TAO LI, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.