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

University of Electronic Science and Technology of China (UESTC)

Status and phase: Completed; Phase 3

Conditions: Chemoradiotherapy; Esophageal Squamous Cell Carcinoma; Enteral Nutrition Therapy

Treatments: Drug: Enteral nutrition; Radiation: radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02399306

scch2015001

Details and patient eligibility

About

This is a randomized, prospective, multicenter study.

Full 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.

Enrollment: 222 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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222 participants in 2 patient groups, including a placebo group

Arm A

Experimental group

Description:

chemoradiotherapy with Enteral Nutrition intervention

Treatment:

Radiation: radiotherapy

Drug: Enteral nutrition

Arm B

Placebo Comparator group

Description:

chemoradiotherapy

Treatment:

Radiation: radiotherapy