Chemoradiotherapy, Enteral Nutrition Therapy, Esophageal Squamous Cell Carcinoma
Conditions
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.
Interventions
DRUGEnteral nutrition
Patients in the Trial Group received concurrent chemoradiotherapy and standardized, whole-course enteral nutrition management.
RADIATIONradiotherapy
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.
Sponsors
Wuhan University
Xiangya Hospital of Central South University
Shanxi Province Cancer Hospital
Shandong Tumor Hospital
Henan Cancer Hospital
Peking University Cancer Hospital & Institute
Hebei Medical University Fourth Hospital
Sichuan Cancer Hospital and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight Change from baseline to the end of treatment | up to 1 month after the treatment | Body weight change from baseline to the end of treatment = body weight at the end of treatment - baseline body weight. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood biochemical examination | up to 1 month after the treatment | albumin, haemoglobin,et al |
| Grade 3-5 toxicity | up to 1 month after the treatment | 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 |
| Maximum Body Weight Change during treatment | up to 1 month after the treatment | Maximum body weight change during treatment= the lowest body weight during treatment - baseline body weight. |
| short-term effect | up to 1 month after the treatment | objective remission rate |
| Overall Survival | at least 2 years | overall survival |
| Completion rate of chemoradiotherapy | up to 1 month after the treatment | The proportion of people who complete all treatment as required |
Countries
China
Outcome results
None listed