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

Study Overview
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Brief Summary
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This is a randomized, prospective, multicenter study.

Detailed Description
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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.

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

Conditions
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Esophageal Squamous Cell Carcinoma, Enteral Nutrition Therapy, Chemoradiotherapy

Intervention / Treatment
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* Drug: Enteral nutrition
* Radiation: radiotherapy


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>chemoradiotherapy with Enteral Nutrition intervention | Drug: Enteral nutrition<br>* Patients in the Trial Group received concurrent chemoradiotherapy and standardized, whole-course enteral nutrition management.<br>Radiation: radiotherapy<br>* 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.<br>|
| Placebo Comparator: Arm B<br>chemoradiotherapy | Radiation: radiotherapy<br>* 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.<br>|

What is the study measuring?
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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 |